FDA 510(k) Applications for Medical Device Product Code "CIW"
(Starch-Dye Bound Polymer, Amylase)
| 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 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
