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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 K021972
Device Name FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
Applicant
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92009
Applicant Contact DOROTHY DEINZER
Correspondent
Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD,  CA  92009
Correspondent Contact DOROTHY DEINZER
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received06/17/2002
Decision Date 08/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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