FDA 510(k) Applications for Medical Device Product Code "CHI"
(Lipase-Esterase, Enzymatic, Photometric, Lipase)

FDA 510(k) Number Applicant Device Name Decision Date
K884596 ABBOTT LABORATORIES ABBOTT A-GENT LIPASE REAGENT 12/06/1988
K874027 ADVOCACY INTERNATIONAL, LTD. LIPASE UV [TOYO] 05/27/1988
K900827 AMERICAN RESEARCH PRODUCTS CO. COLORIMETRIC CHLORIDE PRODUCT #4314125 05/02/1990
K952180 BECKMAN INSTRUMENTS, INC. CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS 08/17/1995
K970905 BECKMAN INSTRUMENTS, INC. SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT 06/04/1997
K802842 BIODYNAMICS CORP. SINGLE VIAL LIPASE TEST KIT 12/18/1980
K811553 BOEHRINGER MANNHEIM CORP. REAGENT SET TRIGLYCERIDES 06/18/1981
K760786 CALBIOCHEM ENZYMATIC LIPASE MAX-PACK REAGENT 01/06/1977
K952816 DUPONT MEDICAL PRODUCTS LIPASE FLEX REAGENT CARTRIDGE 07/20/1995
K845027 EASTMAN KODAK COMPANY KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES 01/18/1985
K875173 EASTMAN KODAK COMPANY KODAK EKTACHEM DT SLIDES (LIPA) 02/24/1988
K961179 EQUAL DIAGNOSTICS, INC. SENTINEL LIPASE LIQUID MODEL 17.401B 07/19/1996
K920337 HERAEUS KULZER, INC. MILES LIPASE SERA-PAK METHOD 03/11/1992
K952647 INSTRUMENTATION LABORATORY CO. IL TEST LIPASE 07/20/1995
K923917 NUCLEAR DIAGNOSTICS, INC. ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY 02/25/1994
K862312 NUCLEAR DIAGNOSTICS, INC. ENZLIPASE, ENZYMATIC LIPASE KIT 09/26/1986
K941085 SIGMA DIAGNOSTICS, INC. LIPASE-PS ASSAY PROCEDURE NO. 805 05/17/1994
K897150 TOYO JOZO CO., LTD. LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT 02/26/1990
K921249 WAKO CHEMICALS, USA, INC. WAKO AUTOKIT LIPASE-COLOR 07/21/1992
K874640 WAKO CHEMICALS, USA, INC. WAKO(TM) AUTOKIT LIPASE 12/22/1987


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