Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K932747 |
Device Name |
CIBA CORNING ACS FREE T3 IMMUNOASSAY |
Applicant |
CIBA CORNING DIAGNOSTICS CORP. |
333 CONEY ST. |
E. WALPOLE,
MA
02032
|
|
Applicant Contact |
William J Pignato |
Correspondent |
CIBA CORNING DIAGNOSTICS CORP. |
333 CONEY ST. |
E. WALPOLE,
MA
02032
|
|
Correspondent Contact |
William J Pignato |
Regulation Number | 862.1710
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/08/1993 |
Decision Date | 12/03/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|