Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

New Search Back To Search Results

CLIA record K061382 and corresponding
510(K) Premarket Notification information

Test System NameBeckman Coulter UniCel DxI 600 Access Immunoassay System  {ACCESS TPO Antibody Reagents} 
Document Number K061382
Analyte NameAnti-Thyroid Peroxidase (TPO) Antibodies
Analyte SpecialtyGeneral Immunology
ComplexityMODERATE
Effective Date06/25/2007

510(k) Premarket Notification Database

Device Classification Name system, test, thyroid autoantibody
510(k) NumberK061382
Device NameACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska,  MN  55318 108
Contactvalynda l machen
Regulation Number866.5870
Classification Product Code
JZO
Subsequent Product Code
JIT
Date Received05/18/2006
Decision Date 07/06/2006
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Statement/Summary/Purged Status Summary only
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No

Database Updated 02/06/2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH