FDA 510(k) Application Details - K922944

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K922944
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant ICN BIOMEDICALS, INC.
3300 HYLAND AVE.
COSTA MESA, CA US
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Contact SUSANNE J GRAVES
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 06/18/1992
Decision Date 02/02/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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