FDA 510(k) Application Details - K021972

Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone

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510(K) Number K021972
Device Name Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD, CA 92009 US
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Contact DOROTHY DEINZER
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Regulation Number 862.1680

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Classification Product Code CDZ
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Date Received 06/17/2002
Decision Date 08/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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