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CHI — Lipase-Esterase, Enzymatic, Photometric, Lipase Class I

FDA Device Classification

Classification Details

Product Code
CHI
Device Class
Class I
Regulation Number
862.1465
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K970905beckman instrumentsSYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTJune 4, 1997
K961179equal diagnosticsSENTINEL LIPASE LIQUID MODEL 17.401BJuly 19, 1996
K952180beckman instrumentsCX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSAugust 17, 1995
K952647instrumentation laboratoryIL TEST LIPASEJuly 20, 1995
K952816dupont medical productsLIPASE FLEX REAGENT CARTRIDGEJuly 20, 1995
K941085sigma diagnosticsLIPASE-PS ASSAY PROCEDURE NO. 805May 17, 1994
K923917nuclear diagnosticsELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYFebruary 25, 1994
K921249wako chemicals usaWAKO AUTOKIT LIPASE-COLORJuly 21, 1992
K920337heraeus kulzerMILES LIPASE SERA-PAK METHODMarch 11, 1992
K900827american research productsCOLORIMETRIC CHLORIDE PRODUCT #4314125May 2, 1990
K897150toyo jozo coLIPASE COLOR [TOYO] SERUM LIPASE TEST KITFebruary 26, 1990
K884596abbott laboratoriesABBOTT A-GENT LIPASE REAGENTDecember 6, 1988
K874027advocacy internationalLIPASE UV [TOYO]May 27, 1988
K875173eastman kodakKODAK EKTACHEM DT SLIDES (LIPA)February 24, 1988
K874640wako chemicals usaWAKO(TM) AUTOKIT LIPASEDecember 22, 1987
K862312nuclear diagnosticsENZLIPASE, ENZYMATIC LIPASE KITSeptember 26, 1986
K845027eastman kodakKODAK EKTACHEM CLINICAL CHEMISTRY SLIDESJanuary 18, 1985
K811553boehringer mannheimREAGENT SET TRIGLYCERIDESJune 18, 1981
K802842biodynamicsSINGLE VIAL LIPASE TEST KITDecember 18, 1980
K760786calbiochemENZYMATIC LIPASE MAX-PACK REAGENTJanuary 6, 1977