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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K862483
Device Name PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT
Applicant
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Applicant Contact NEIL CHIAMORI
Correspondent
Pantex, Div. Bio-Analysis, Inc.
1737 21st St.
Santa Monica,  CA  90404
Correspondent Contact NEIL CHIAMORI
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received06/30/1986
Decision Date 01/14/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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