|
Device |
glucose oxidase, glucose |
Product Code | CGA |
Regulation Number |
862.1345
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT POINT OF CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ABBOTT POINT OF CARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACON LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALERE SAN DIEGO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALLIANCE INTERNATIONAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APEX BIO TECHNOLOGY CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APEX BIOTECHNOLOGY CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
1. K090043 AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MO ...
|
2. K101204 MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S ...
|
3. K102037 AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM ...
|
4. K113208 GAL-1A BLOOD GLUCOSE MONITORING SYSTEM
|
5. K113547 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOO ...
|
6. K120448 MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD ...
|
7. K131750 AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
|
8. K142689 GAL-1F Blood Glucose Monitoring System, GAL-1F Pro ...
|
ARKRAY FACTORY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARKRAY FACTORY USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BESTGEN BIOTECH CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BROADMASTER BIOTECH CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIATRON GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EOSHEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPOCAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPS BIO TECHNOLOGY CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FORA CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUBDIC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
I-SENS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INFOPIA CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTRUMENTATION LABORATORY CO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSTRUMENTATION LABORATORY CO. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVA BIOMEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ORTHO CLINICAL DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORTHO-CLINICAL DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILOSYS CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLYMER TECHNOLOGY SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
SENDX MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEPPIM S.A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIMPLE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPHERE MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abbott Point Of Care Inc. |
II |
Dec-10-2010 |
2 |
Abbott Point of Care Inc. |
III |
Sep-23-2010 |
3 |
Abbott Point of Care Inc. |
II |
Mar-15-2010 |
4 |
Abbott Point of Care Inc. |
III |
Feb-24-2010 |
5 |
Abbott Point of Care Inc. |
II |
Sep-30-2009 |
6 |
Alere San Diego, Inc. |
II |
Apr-30-2024 |
7 |
Alere San Diego, Inc. |
II |
Aug-06-2022 |
8 |
Alere San Diego, Inc. |
III |
Nov-22-2013 |
9 |
Arkray Factory USA, Inc. |
I |
Jan-15-2016 |
10 |
Beckman Coulter Inc. |
II |
Sep-09-2010 |
11 |
Biosite Inc Dba Innovacon Inc. |
II |
Jun-01-2011 |
12 |
DIABETIC SUPPLY OF SUNCOAST, INC. |
I |
Jul-22-2014 |
13 |
ELITech Clinical Systems SAS |
II |
Nov-05-2015 |
14 |
Epocal |
II |
Aug-14-2013 |
15 |
Epocal Inc |
II |
Jul-19-2012 |
16 |
Hemo Cue, Inc. |
III |
Jan-20-2012 |
17 |
Hemo Cue, Inc. |
II |
Mar-30-2011 |
18 |
HemoCue AB |
II |
Sep-11-2013 |
19 |
Instrumentation Laboratory Co. |
II |
May-10-2011 |
20 |
JAS Diagnostics Inc. |
II |
Jun-25-2014 |
21 |
Medline Industries Inc |
II |
Nov-22-2019 |
22 |
Nova Biomedical Corporation |
II |
Jan-09-2014 |
23 |
Nova Biomedical Corporation |
II |
Apr-19-2013 |
24 |
Nova Biomedical Corporation |
II |
Jun-10-2010 |
25 |
Ortho-Clinical Diagnostics |
II |
Aug-06-2019 |
26 |
Ortho-Clinical Diagnostics |
II |
Oct-17-2016 |
27 |
Ortho-Clinical Diagnostics |
II |
Nov-15-2013 |
28 |
Osmetech Inc |
II |
Jun-25-2015 |
29 |
Pointe Scientific, Inc. |
II |
Mar-12-2009 |
30 |
Polymer Technology Systems, Inc. |
II |
May-23-2019 |
31 |
Polymer Technology Systems, Inc. |
II |
Mar-05-2010 |
32 |
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. |
III |
Sep-14-2022 |
33 |
Radiometer America Inc |
II |
Dec-24-2014 |
34 |
Randox Laboratories Ltd. |
II |
Oct-31-2023 |
35 |
Roche Diagnostics Operations, Inc. |
II |
Feb-02-2015 |
36 |
Siemens Healthcare Diagnostics Inc |
II |
Sep-15-2020 |
37 |
Siemens Healthcare Diagnostics, Inc |
II |
Jul-02-2015 |
38 |
Siemens Healthcare Diagnostics, Inc. |
II |
May-11-2016 |
39 |
Sterling Diagnostics, Inc. |
III |
Dec-29-2016 |
|
|
|
|