FDA.reportPublic FDA data

510(k) K234005

Device
Access CK-MB
Applicant
Beckman Coulter, Inc.
510(k) number
K234005
Product code
JHX
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-16
Date received
2023-12-19
Regulation
862.1215
Classification name
Fluorometric Method, Cpk Or Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neha Desai
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JHX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics2022-01-28
K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps2017-09-21
K120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical Aps2012-11-21
K081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku Iatron2009-08-17
K051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.2005-09-08
K041596ARCHITECT STAT CK-MB IMMUNOASSAYFisher Diagnostics2004-07-21
K033747RAMP CK-MB ASSAYResponse Biomedical Corp.2004-05-17
K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IDiagnostic Products Corp.2004-01-21
K030012CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372Beckman Coulter, Inc.2003-01-17
K022118IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)Diagnostic Products Corp.2002-07-22
K013118MODIFICATION TO ALPHA DX SYSTEMFirst Medical, Inc.2001-10-15
K004002IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)Diagnostic Products Corp.2001-02-14
K000716ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Coulter, Inc.2000-03-20
K994439ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306Beckman Coulter, Inc.2000-01-14
K993068VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORSOrtho-Clinical Diagnostics1999-10-04