Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K130990 |
Device Name |
VARIANT(TM) II TURBO HBA1C KIT - 2.0 |
Applicant |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE |
HERCULES,
CA
94547
|
|
Applicant Contact |
EBONY MCKINNIES |
Correspondent |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE |
HERCULES,
CA
94547
|
|
Correspondent Contact |
EBONY MCKINNIES |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 04/10/2013 |
Decision Date | 05/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|