Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K121534 |
Device Name |
CONE-TROL HEMOGLOBIN A1C CONTROL SET |
Applicant |
CONE BIOPRODUCTS |
1012 N. AUSTIN ST. |
SEGUIN,
TX
78155
|
|
Applicant Contact |
GAIL SCHIEVELBEIN |
Correspondent |
CONE BIOPRODUCTS |
1012 N. AUSTIN ST. |
SEGUIN,
TX
78155
|
|
Correspondent Contact |
GAIL SCHIEVELBEIN |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 06/20/2012 |
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
|