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


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