FDA.reportPublic FDA data

510(k) K231832

Device
Access Myoglobin
Applicant
Beckman Coulter, Inc.
510(k) number
K231832
Product code
DDR
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-18
Date received
2023-06-22
Regulation
866.5680
Classification name
Myoglobin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kate Oelberg
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 DDR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme Laboratories2013-06-07
K122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.2012-10-03
K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche Diagnostics2009-10-16
K080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.2009-02-20
K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.2006-07-21
K042924ARCHITECT STAT MYO IMMUNOASSAYFisher Diagnostics2005-01-24
K042982QUANTEX MYOGLOBINInstrumentation Laboratory CO2004-12-22
K033300VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.2003-11-05
K021229MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244Beckman Coulter, Inc.2002-06-28
K012040RAMP MYOGLOBIN ASSAYResponse Biomedical Corp.2001-12-18
K010700RANDOX MYOGLOBINRandox Laboratories, Ltd.2001-05-08
K000196ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316Beckman Coulter, Inc.2000-02-18
K992976K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATORKamiya Biomedical Co.1999-11-01
K991796IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5Diagnostic Products Corp.1999-06-09
K991277MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5Diagnostic Products Corp.1999-04-27