Device Classification Name |
radioimmunoassay, thyroid-stimulating hormone
|
510(k) Number |
K030912 |
Device Name |
THYRO TEST |
Applicant |
THRYOTEC |
163 CABOT STREET |
BEVERLY,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
THRYOTEC |
163 CABOT STREET |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 862.1690
|
Classification Product Code |
|
Date Received | 03/24/2003 |
Decision Date | 07/25/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|