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Panels › Clinical Chemistry › Product code CIW · Class 2

Starch-Dye Bound Polymer, Amylase

Regulation 862.1070

0510(k)s in 12 months (8 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in CIW

Company510(k)sRecalls
Ortho-Clinical Diagnostics05
Bio-Analytics Laboratories, Inc.10
Boehringer Mannheim Corp.10
Calbiochem-Behring Corp.10
Data Medical Associates, Inc.10
Eastman Kodak Company10
Em Diagnostic Systems, Inc.10
Olympus Corp.10
Pharmacia, Inc.10
Decided510(k)Device and applicantCode
Oct 28, 1993K931559DMA AMYLASE PROCEDURE
Data Medical Associates, Inc.
CIW
Oct 19, 1992K924339OLYMPUS AMYLASE REAGENT
Olympus Corp.
CIW
Jan 11, 1989K884382AMYLASE TEST (AMYL) ITEM NUMBER: 65653
Em Diagnostic Systems, Inc.
CIW
Mar 5, 1985K850639ENZYMATIC ALPHA-AMYLASE REAGENT KIT
Bio-Analytics Laboratories, Inc.
CIW
Aug 3, 1981K812027KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
Eastman Kodak Company
CIW
May 13, 1981K810584PHADEBAS ISOAMYLASE TEST
Pharmacia, Inc.
CIW
Mar 31, 1981K810669PANTRAK E.K.
Calbiochem-Behring Corp.
CIW
Mar 2, 1979K782032UNITEST AMYLASE
Boehringer Mannheim Corp.
CIW

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