Device Classification Name |
calibrator, multi-analyte mixture
|
510(k) Number |
K921678 |
Device Name |
CIBA CORNING ACS FOLATE 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 | 862.1150
|
Classification Product Code |
|
Date Received | 04/08/1992 |
Decision Date | 06/09/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|