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Panels › Clinical Chemistry › Product code CHI · Class 1

Lipase-Esterase, Enzymatic, Photometric, Lipase

Regulation 862.1465

0510(k)s in 12 months (20 all time)
0recalls in 12 months (22 all time)
9recalls that name a 510(k)
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Top companies in CHI

Decided510(k)Device and applicantCode
Jun 4, 1997K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
Beckman Instruments, Inc.
CHI
Jul 19, 1996K961179SENTINEL LIPASE LIQUID MODEL 17.401B
Equal Diagnostics, Inc.
CHI
Aug 17, 1995K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
Beckman Instruments, Inc.
CHI
Jul 20, 1995K952816LIPASE FLEX REAGENT CARTRIDGE
Dupont Medical Products
CHI
Jul 20, 1995K952647IL TEST LIPASE
Instrumentation Laboratory CO
CHI
May 17, 1994K941085LIPASE-PS ASSAY PROCEDURE NO. 805
Sigma Diagnostics, Inc.
CHI
Feb 25, 1994K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
Nuclear Diagnostics, Inc.
CHI
Jul 21, 1992K921249WAKO AUTOKIT LIPASE-COLOR
Wako Chemicals USA, Inc.
CHI
Mar 11, 1992K920337MILES LIPASE SERA-PAK METHOD
Heraeus Kulzer, Inc.
CHI
May 2, 1990K900827COLORIMETRIC CHLORIDE PRODUCT #4314125
American Research Products Co.
CHI
Feb 26, 1990K897150LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
Toyo Jozo Co., Ltd.
CHI
Dec 6, 1988K884596ABBOTT A-GENT LIPASE REAGENT
Abbott Laboratories
CHI
May 27, 1988K874027LIPASE UV [TOYO]
Advocacy International, Ltd.
CHI
Feb 24, 1988K875173KODAK EKTACHEM DT SLIDES (LIPA)
Eastman Kodak Company
CHI
Dec 22, 1987K874640WAKO(TM) AUTOKIT LIPASE
Wako Chemicals USA, Inc.
CHI
Sep 26, 1986K862312ENZLIPASE, ENZYMATIC LIPASE KIT
Nuclear Diagnostics, Inc.
CHI
Jan 18, 1985K845027KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
Eastman Kodak Company
CHI
Jun 18, 1981K811553REAGENT SET TRIGLYCERIDES
Boehringer Mannheim Corp.
CHI
Dec 18, 1980K802842SINGLE VIAL LIPASE TEST KIT
Biodynamics Corp.
CHI
Jan 6, 1977K760786ENZYMATIC LIPASE MAX-PACK REAGENT
Calbiochem
CHI

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