Device Classification Name |
urinary homocystine (nonquantitative) test system
|
510(k) Number |
K121053 |
Device Name |
DIAZYME HOMOCYSTEINE POC TEST KIT |
Applicant |
DIAZYME LABORATORIES |
12889 GREGG COURT |
POWAY,
CA
92064
|
|
Applicant Contact |
Abhijit Datta |
Correspondent |
DIAZYME LABORATORIES |
12889 GREGG COURT |
POWAY,
CA
92064
|
|
Correspondent Contact |
Abhijit Datta |
Regulation Number | 862.1377
|
Classification Product Code |
|
Date Received | 04/06/2012 |
Decision Date | 07/31/2012 |
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
|