Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K963687 |
Device Name |
AIA-PACK FT3 ASSAY |
Applicant |
TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. |
SUITE D |
FOSTER CITY,
CA
94404
|
|
Applicant Contact |
LORI ROBINSON |
Correspondent |
TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. |
SUITE D |
FOSTER CITY,
CA
94404
|
|
Correspondent Contact |
LORI ROBINSON |
Regulation Number | 862.1710
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/16/1996 |
Decision Date | 11/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|