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 |