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JHX — Fluorometric Method, Cpk Or Isoenzymes Class II

FDA Device Classification

Classification Details

Product Code
JHX
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
K234005beckman coulterAccess CK-MBFebruary 16, 2024
K212648ortho clinical diagnosticsVITROS Immunodiagnostic Products CK-MB Reagent PackJanuary 28, 2022
K163462radiometer medical apsAQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXSeptember 21, 2017
K120326radiometer medical apsAQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMNovember 21, 2012
K081360mitsubishi kagaku iatronPATHFAST CK-MB-II, PATHFAST MYO-IIAugust 17, 2009
K051650dade behringSTRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CSeptember 8, 2005
K041596fisher diagnosticsARCHITECT STAT CK-MB IMMUNOASSAYJuly 21, 2004
K033747response biomedicalRAMP CK-MB ASSAYMay 17, 2004
K034055diagnostic productsIMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IJanuary 21, 2004
K030012beckman coulterCK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 ANDJanuary 17, 2003
K022118diagnostic productsIMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)July 22, 2002
K013118first medicalMODIFICATION TO ALPHA DX SYSTEMOctober 15, 2001
K004002diagnostic productsIMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB,February 14, 2001
K000716beckman coulterACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZERMarch 20, 2000
K994439beckman coulterACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 333January 14, 2000
K993068ortho-clinical diagnosticsVITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PROctober 4, 1999
K991797diagnostic productsIMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5June 9, 1999
K984067dade behringSTRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAKJanuary 13, 1999
K981099dade behringSTRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAKMay 26, 1998
K980012ac biochemicalsCREATINE KINASE REAGENTFebruary 25, 1998