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JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
JHS
Device Class
Class II
Regulation Number
862.1215
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K160570roche diagnostics operations (rdo)Creatine KinaseMay 25, 2016
K102706sentinel chCKMB UDR ASSAYAugust 19, 2011
K082226alfa wassermann diagnostic technologiesS40 CREATINE KINASE (CK)September 18, 2008
K062128dade behringTHE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSAugust 21, 2006
K990439caresideCARESIDE CKApril 19, 1999
K990434caresideCARESIDE CKMBApril 19, 1999
K981495diagnostic productsIMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS)June 10, 1998
K962126ciba corning diagnosticsACS CKMB II IMMUNOASSAYJune 21, 1996
K952250dade intlSTRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMEJuly 17, 1995
K945083bio-rad laboratoriesACCESS CK-MB REAGENTSNovember 21, 1994
K943024dupont medical productsKINASE ISOENZYMEAugust 2, 1994
K941584dupont medical productsCREATINE KINASE METHODJuly 6, 1994
K903025roche diagnostic systemsROCHE ISOMUNE- CKAugust 9, 1990
K900806baxter healthcareSTRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYMarch 23, 1990
K883223intl. immunoassay laboratoriesCHECK-MMSeptember 30, 1988
K872029sclavoUNI-FAST CREATINE KINASE TEST (CK)June 17, 1987
K861387eastman kodakKODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)June 27, 1986
K855188technostics intlCPK (UV) REAGENT KITMarch 5, 1986
K854708coulter electronicsDART CK-MB REAGENT SYSTEMDecember 30, 1985
K843007intl. immunoassay laboratoriesCARDI-CK EIA TEST KIT CK-MB ISOENZYMESeptember 7, 1984