Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K120615 |
Device Name |
ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE |
Applicant |
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
9975 SUMMERS RIDGE RD |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
EDWARD BREHM, PH.D. |
Correspondent |
ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN |
9975 SUMMERS RIDGE RD |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
EDWARD BREHM, PH.D. |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/29/2012 |
Decision Date | 05/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|