FDA 510(k) Application Details - K072264

Device Classification Name Radioimmunoassay, Human Chorionic Gonadotropin

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510(K) Number K072264
Device Name Radioimmunoassay, Human Chorionic Gonadotropin
Applicant Qualigen, Inc.
2042 CORTE DEL NOGAL
CARLSBAD, CA 92011 US
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Contact MICHAEL S POIRIER
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Regulation Number 862.1155

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Classification Product Code JHI
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Date Received 08/15/2007
Decision Date 12/06/2007
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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