Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K913493 |
Device Name |
AIA-PACK FT4 |
Applicant |
TOSOH CORP. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
PATRICIA B SHRADER |
Correspondent |
TOSOH CORP. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
PATRICIA B SHRADER |
Regulation Number | 862.1695 |
Classification Product Code |
|
Date Received | 08/06/1991 |
Decision Date | 09/10/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
Recalls |
CDRH Recalls
|
|
|