FDA 510(k) Applications for Medical Device Product Code "JHX"
(Fluorometric Method, Cpk Or Isoenzymes)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K980012 | AC BIOCHEMICALS, INC. | CREATINE KINASE REAGENT | 02/25/1998 |
| K000716 | BECKMAN COULTER, INC. | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER | 03/20/2000 |
| K994439 | BECKMAN COULTER, INC. | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 | 01/14/2000 |
| K030012 | BECKMAN COULTER, INC. | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 | 01/17/2003 |
| K962549 | BIOMERIEUX VITEK, INC. | VIDAS CREATINE KINASE MB ASSAY 30-421 | 08/30/1996 |
| K973126 | BIOSITE INCORPORATED | TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I | 10/06/1997 |
| K984067 | DADE BEHRING, INC. | STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK | 01/13/1999 |
| K051650 | DADE BEHRING, INC. | STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. | 09/08/2005 |
| K981099 | DADE BEHRING, INC. | STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK | 05/26/1998 |
| K972782 | DADE INTL., INC. | DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | 08/15/1997 |
| K034055 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I | 01/21/2004 |
| K004002 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) | 02/14/2001 |
| K022118 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | 07/22/2002 |
| K991797 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 | 06/09/1999 |
| K013118 | FIRST MEDICAL, INC. | MODIFICATION TO ALPHA DX SYSTEM | 10/15/2001 |
| K041596 | FISHER DIAGNOSTICS | ARCHITECT STAT CK-MB IMMUNOASSAY | 07/21/2004 |
| K081360 | MITSUBISHI KAGAKU IATRON | PATHFAST CK-MB-II, PATHFAST MYO-II | 08/17/2009 |
| K212648 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products CK-MB Reagent Pack | 01/28/2022 |
| K993068 | ORTHO-CLINICAL DIAGNOSTICS | VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS | 10/04/1999 |
| K120326 | RADIOMETER MEDICAL APS | AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE | 11/21/2012 |
| K163462 | Radiometer Medical ApS | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | 09/21/2017 |
| K033747 | RESPONSE BIOMEDICAL CORP. | RAMP CK-MB ASSAY | 05/17/2004 |
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