Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K070819 |
Device Name |
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, |
Applicant |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
4000 ALFRED NOBEL DR. |
HERCULES,
CA
94547
|
|
Applicant Contact |
JACKIE H BUCKLEY |
Correspondent |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
4000 ALFRED NOBEL DR. |
HERCULES,
CA
94547
|
|
Correspondent Contact |
JACKIE H BUCKLEY |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/26/2007 |
Decision Date | 06/25/2007 |
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
|
Recalls |
CDRH Recalls
|
|
|