|
Device |
hexokinase, glucose |
Product Code | CFR |
Regulation Number |
862.1345
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIATRON US, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELITECHGROUP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI CHEMICAL DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HORIBA ABX SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLYMEDCO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROCHE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
1. K092603 COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
|
2. K191899 Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecs ...
|
3. K220134 cobas pure integrated solutions, Glucose HK Gen.3, ...
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOKYO BOEKI MEDISYS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|