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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 K182521
Device Name FastPack IP Sex Hormone Binding Globulin Immunoassay
Applicant
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Applicant Contact Wajdi Abdul-Ahad
Correspondent
Qualigen, Inc.
2042 Corte Del Nogal
Carlsbad,  CA  92011
Correspondent Contact Wajdi Abdul-Ahad
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received09/13/2018
Decision Date 01/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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