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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 K101388
Device Name FASTPACK TESTO IMMUNOASSAY
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Suite B
Carlsbad,  CA  92011 -1438
Applicant Contact MICHAEL S POIRIER
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Suite B
Carlsbad,  CA  92011 -1438
Correspondent Contact MICHAEL S POIRIER
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received05/17/2010
Decision Date 02/18/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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