FDA 510(k) Application Details - K030329

Device Classification Name Radioimmunoassay, Free Thyroxine

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510(K) Number K030329
Device Name Radioimmunoassay, Free Thyroxine
Applicant Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD, CA 92009-1410 US
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Contact DOROTHY DEINZER
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Regulation Number 862.1695

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Classification Product Code CEC
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Date Received 01/31/2003
Decision Date 07/03/2003
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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