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FDA 510(k) Applications for Medical Device Product Code "CIW"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K850639 | BIO-ANALYTICS LABORATORIES, INC. | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | 03/05/1985 |
K782032 | BOEHRINGER MANNHEIM CORP. | UNITEST AMYLASE | 03/02/1979 |
K810669 | CALBIOCHEM-BEHRING CORP. | PANTRAK E.K. | 03/31/1981 |
K931559 | DATA MEDICAL ASSOCIATES, INC. | DMA AMYLASE PROCEDURE | 10/28/1993 |
K812027 | EASTMAN KODAK COMPANY | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | 08/03/1981 |
K884382 | EM DIAGNOSTIC SYSTEMS, INC. | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | 01/11/1989 |
K924339 | OLYMPUS CORP. | OLYMPUS AMYLASE REAGENT | 10/19/1992 |
K810584 | PHARMACIA, INC. | PHADEBAS ISOAMYLASE TEST | 05/13/1981 |