Device Classification Name |
Radioimmunoassay, Total Thyroxine
|
510(k) Number |
K790477 |
Device Name |
TY RIA KIT, AUTOMATED ASSAY SYSTEM |
Applicant |
E. R. SQUIBB & SONS, INC. |
40 W 57TH ST. |
NEW YORK,
NY
10019
|
|
Correspondent |
E. R. SQUIBB & SONS, INC. |
40 W 57TH ST. |
NEW YORK,
NY
10019
|
|
Regulation Number | 862.1700
|
Classification Product Code |
|
Date Received | 03/09/1979 |
Decision Date | 04/26/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|