Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K122472 |
Device Name |
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM |
Applicant |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE |
HERCULES,
CA
94547
|
|
Applicant Contact |
JACKIE BUCKLEY |
Correspondent |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
4000 ALFRED NOBEL DRIVE |
HERCULES,
CA
94547
|
|
Correspondent Contact |
JACKIE BUCKLEY |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 08/14/2012 |
Decision Date | 10/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|