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510(k) K000196

Device
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
Applicant
BECKMAN COULTER, INC.
510(k) number
K000196
Product code
DDR  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-18
Date received
2000-01-21
Regulation
866.5680
Classification name
Myoglobin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAN OLSEN
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
K231832Access MyoglobinBeckman Coulter, Inc.2023-09-18
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
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

Legacy Summary#

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FDA Review#

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