FDA 510(k) Application Details - K810754

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K810754
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant PCL-RIA, INC.

, US
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 03/20/1981
Decision Date 03/31/1981
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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