Panels › Clinical Chemistry › Product code JHX · Class 2
Fluorometric Method, Cpk Or Isoenzymes
Regulation 862.1215
0510(k)s in 12 months (48 all time)
0recalls in 12 months (15 all time)
15recalls that name a 510(k)
Top companies in JHX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 2024 | K234005 | Access CK-MB Beckman Coulter, Inc. | JHX |
| Jan 28, 2022 | K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack Ortho Clinical Diagnostics, GB | JHX |
| Sep 21, 2017 | K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX Radiometer Medical Aps, DK | JHX |
| Nov 21, 2012 | K120326 | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE Radiometer Medical Aps, DK | JHX |
| Aug 17, 2009 | K081360 | PATHFAST CK-MB-II, PATHFAST MYO-II Mitsubishi Kagaku Iatron | JHX |
| Sep 8, 2005 | K051650 | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. Dade Behring, Inc. | JHX |
| Jul 21, 2004 | K041596 | ARCHITECT STAT CK-MB IMMUNOASSAY Fisher Diagnostics | JHX |
| May 17, 2004 | K033747 | RAMP CK-MB ASSAY Response Biomedical Corp., CA | JHX |
| Jan 21, 2004 | K034055 | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I Diagnostic Products Corp. | JHX |
| Jan 17, 2003 | K030012 | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 Beckman Coulter, Inc. | JHX |
| Jul 22, 2002 | K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) Diagnostic Products Corp. | JHX |
| Oct 15, 2001 | K013118 | MODIFICATION TO ALPHA DX SYSTEM First Medical, Inc. | JHX |
| Feb 14, 2001 | K004002 | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) Diagnostic Products Corp. | JHX |
| Mar 20, 2000 | K000716 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Coulter, Inc. | JHX |
| Jan 14, 2000 | K994439 | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 Beckman Coulter, Inc. | JHX |
| Oct 4, 1999 | K993068 | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS Ortho-Clinical Diagnostics | JHX |
| Jun 9, 1999 | K991797 | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 Diagnostic Products Corp. | JHX |
| Jan 13, 1999 | K984067 | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK Dade Behring, Inc. | JHX |
| May 26, 1998 | K981099 | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK Dade Behring, Inc. | JHX |
| Feb 25, 1998 | K980012 | CREATINE KINASE REAGENT Ac Biochemicals, Inc. | JHX |
| Oct 6, 1997 | K973126 | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I Biosite Incorporated | JHX |
| Aug 15, 1997 | K972782 | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY Dade Intl., Inc. | JHX |
| Aug 30, 1996 | K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 Biomerieux Vitek, Inc. | JHX |
| Apr 22, 1992 | K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MB Intl. Immunoassay Laboratories, Inc. | JHX |
| Sep 27, 1991 | K913298 | AIA-PACK CK-MB Tosoh Corp. | JHX |
| Apr 3, 1991 | K911121 | CIBA CORNING ACS CKMB IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHX |
| Nov 6, 1990 | K903441 | MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS Intl. Immunoassay Laboratories, Inc. | JHX |
| Mar 13, 1989 | K890543 | IMPRES-MB REAGENT A AND REAGENT B Intl. Immunoassay Laboratories, Inc. | JHX |
| May 16, 1988 | K881267 | BIOTROL CK MONOEACTIF Biotrol, USA, Inc. | JHX |
| Apr 28, 1988 | K881237 | CREATINE KINASE (CK) REAGENT SET Tech-Neal Scientific, Inc. | JHX |
| Nov 23, 1987 | K874144 | TITAN GEL REP CPK-6 HV Helena Laboratories | JHX |
| Oct 20, 1987 | K873399 | TITAN GEL CPK REP SYSTEM Helena Laboratories | JHX |
| Sep 29, 1987 | K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY American Dade | JHX |
| May 26, 1987 | K870987 | CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHX |
| May 7, 1984 | K840549 | CK-B RIA KIT Diagnostic Systems Laboratories, Inc. | JHX |
| Jan 18, 1982 | K813573 | CARDIOTRAC CORNING CK ISOENZYME SUBST Corning Medical & Scientific | JHX |
| Dec 17, 1981 | K813087 | ABURIA-CK RIA TEST KIT Intl. Immunoassay Laboratories, Inc. | JHX |
| Oct 19, 1981 | K812759 | NML CK-MB RIA Nuclear Medical Laboratories, Inc. | JHX |
| Jan 9, 1981 | K802826 | PARAGON ELECTRO. CREATINE KINASE TEST KI Beckman Instruments, Inc. | JHX |
| Sep 26, 1980 | K801728 | EMBRIA-CK Intl. Immunoassay Laboratories, Inc. | JHX |
| Jul 14, 1980 | K801318 | HELENA ULTRA SENSITIVE CPK REAGENT/DILUE Helena Laboratories | JHX |
| Mar 20, 1980 | K800544 | CORNING TRANSPHOR Corning Medical & Scientific | JHX |
| Jan 16, 1980 | K792504 | RIA-QUANT CK-MB TEST KIT Mallinckrodt Critical Care | JHX |
| Nov 15, 1979 | K791582 | CARDIO CK-B RIA KIT Nuclear Medical Systems, Inc. | JHX |
| Mar 21, 1979 | K790294 | BUFFER, CORNING MOPSO Corning Medical & Scientific | JHX |
| Sep 15, 1977 | K771605 | CREATINE KINASE ISOENZYME SUBSTRATE SET Pfizer Pharmaceuticals | JHX |
| Sep 2, 1977 | K771324 | 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID Corning Medical & Scientific | JHX |
| Oct 29, 1976 | K760591 | SIGMA PROCEDURE NO. 745 - EP.REAGENT SY Sigma Chemical Co. | JHX |
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