Atlas FDA

JHX

48 FDA 510(k) clearances · Product code

49 daysmedian time to decision
168 days90th percentile
48clearances measured

FDA profile

Official device name
Fluorometric Method, Cpk Or Isoenzymes
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2012: 18 · 2013: 8 · 2014: 17 · 2015: 8 · 2016: 10 · 2018: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Access CK-MB (K234005)Beckman Coulter, Inc.2024-02-16
VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648)Ortho Clinical Diagnostics2022-01-28
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462)Radiometer Medical Aps2017-09-21
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326)Radiometer Medical Aps2012-11-21
PATHFAST CK-MB-II, PATHFAST MYO-II (K081360)Mitsubishi Kagaku Iatron2009-08-17
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650)Dade Behring, Inc.2005-09-08
ARCHITECT STAT CK-MB IMMUNOASSAY (K041596)Fisher Diagnostics2004-07-21
RAMP CK-MB ASSAY (K033747)Response Biomedical Corp.2004-05-17
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055)Diagnostic Products Corp.2004-01-21
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012)Beckman Coulter, Inc.2003-01-17
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (K022118)Diagnostic Products Corp.2002-07-22
MODIFICATION TO ALPHA DX SYSTEM (K013118)First Medical, Inc.2001-10-15
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) (K004002)Diagnostic Products Corp.2001-02-14
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER (K000716)Beckman Coulter, Inc.2000-03-20
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 (K994439)Beckman Coulter, Inc.2000-01-14
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS (K993068)Ortho-Clinical Diagnostics1999-10-04
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 (K991797)Diagnostic Products Corp.1999-06-09
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK (K984067)Dade Behring, Inc.1999-01-13
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK (K981099)Dade Behring, Inc.1998-05-26
CREATINE KINASE REAGENT (K980012)Ac Biochemicals, Inc.1998-02-25
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I (K973126)Biosite Incorporated1997-10-06
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K972782)Dade Intl., Inc.1997-08-15
VIDAS CREATINE KINASE MB ASSAY 30-421 (K962549)Biomerieux Vitek, Inc.1996-08-30
MYDAS(TM)-MB2/MYDAS(TM)-MB (K913380)Intl. Immunoassay Laboratories, Inc.1992-04-22
AIA-PACK CK-MB (K913298)Tosoh Corp.1991-09-27
CIBA CORNING ACS CKMB IMMUNOASSAY (K911121)Ciba Corning Diagnostics Corp.1991-04-03
MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS (K903441)Intl. Immunoassay Laboratories, Inc.1990-11-06
IMPRES-MB REAGENT A AND REAGENT B (K890543)Intl. Immunoassay Laboratories, Inc.1989-03-13
BIOTROL CK MONOEACTIF (K881267)Biotrol, USA, Inc.1988-05-16
CREATINE KINASE (CK) REAGENT SET (K881237)Tech-Neal Scientific, Inc.1988-04-28
TITAN GEL REP CPK-6 HV (K874144)Helena Laboratories1987-11-23
TITAN GEL CPK REP SYSTEM (K873399)Helena Laboratories1987-10-20
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K873171)American Dade1987-09-29
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY (K870987)Ciba Corning Diagnostics Corp.1987-05-26
CK-B RIA KIT (K840549)Diagnostic Systems Laboratories, Inc.1984-05-07
CARDIOTRAC CORNING CK ISOENZYME SUBST (K813573)Corning Medical & Scientific1982-01-18
ABURIA-CK RIA TEST KIT (K813087)Intl. Immunoassay Laboratories, Inc.1981-12-17
NML CK-MB RIA (K812759)Nuclear Medical Laboratories, Inc.1981-10-19
PARAGON ELECTRO. CREATINE KINASE TEST KI (K802826)Beckman Instruments, Inc.1981-01-09
EMBRIA-CK (K801728)Intl. Immunoassay Laboratories, Inc.1980-09-26
HELENA ULTRA SENSITIVE CPK REAGENT/DILUE (K801318)Helena Laboratories1980-07-14
CORNING TRANSPHOR (K800544)Corning Medical & Scientific1980-03-20
RIA-QUANT CK-MB TEST KIT (K792504)Mallinckrodt Critical Care1980-01-16
CARDIO CK-B RIA KIT (K791582)Nuclear Medical Systems, Inc.1979-11-15
BUFFER, CORNING MOPSO (K790294)Corning Medical & Scientific1979-03-21
CREATINE KINASE ISOENZYME SUBSTRATE SET (K771605)Pfizer Pharmaceuticals1977-09-15
3-(N-MORPHOLINS)-PROPANE SULFONIC ACID (K771324)Corning Medical & Scientific1977-09-02
SIGMA PROCEDURE NO. 745 - EP.REAGENT SY (K760591)Sigma Chemical Co.1976-10-29

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Every clearance here is in the API, with alerts when new ones post.