Device Classification Name |
Radioimmunoassay, Total Triiodothyronine
|
510(k) Number |
K991692 |
Device Name |
CHIRON DIAGNOSTICS ACS: 180 FT3 |
Applicant |
CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Applicant Contact |
William J Pignato |
Correspondent |
CHIRON DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Correspondent Contact |
William J Pignato |
Regulation Number | 862.1710
|
Classification Product Code |
|
Date Received | 05/18/1999 |
Decision Date | 06/18/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|