Device Classification Name |
Radioimmunoassay, Thyroid-Stimulating Hormone
|
510(k) Number |
K090846 |
Device Name |
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT |
Applicant |
PERKINELMER, INC. |
8275 CARLOWAY ROAD |
INDIANAPOLIS,
IN
46236
|
|
Applicant Contact |
KAY A TAYLOR |
Correspondent |
PERKINELMER, INC. |
8275 CARLOWAY ROAD |
INDIANAPOLIS,
IN
46236
|
|
Correspondent Contact |
KAY A TAYLOR |
Regulation Number | 862.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2009 |
Decision Date | 09/03/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|