FDA 510(k) Application Details - K900779

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K900779
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN US
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Contact CHERI EMMONS
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 02/20/1990
Decision Date 04/03/1990
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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