Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K083891 |
Device Name |
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 |
Applicant |
MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL |
WINDHAM,
ME
04062 -5365
|
|
Applicant Contact |
HOLLY CRESSMAN |
Correspondent |
MAINE STANDARDS CO. |
765 ROOSEVELT TRAIL |
WINDHAM,
ME
04062 -5365
|
|
Correspondent Contact |
HOLLY CRESSMAN |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 12/29/2008 |
Decision Date | 03/23/2009 |
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
|
|
|