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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K992665
Device Name MACRA LP(A) ENZYME IMMUNOASSAY KIT
Applicant
Trinity Biotech USA
P.O. Box 1059
Jamestown,  NY  14702
Applicant Contact WAYNE A KVETKOSKY
Correspondent
Trinity Biotech USA
P.O. Box 1059
Jamestown,  NY  14702
Correspondent Contact WAYNE A KVETKOSKY
Regulation Number866.5600
Classification Product Code
DFC  
Date Received08/09/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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