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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
510(k) Number K140455
Device Name CAPTIA MEASLES IGM
Applicant
Trinity Biotech USA
2823 Girts Rd.
Jamestown,  NY  14701
Applicant Contact Bonnie B DeJoy
Correspondent
Trinity Biotech USA
2823 Girts Rd.
Jamestown,  NY  14701
Correspondent Contact Bonnie B DeJoy
Regulation Number866.3520
Classification Product Code
PCL  
Date Received02/24/2014
Decision Date 05/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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