FDA 510(k) Application Details - K864144

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K864144
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant IMMUCHEM CORP.
P.O. BOX 6227
2015 EAST UNIVERSITY DRIVE
CARSON, CA US
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Contact BURNS, PHD
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 10/22/1986
Decision Date 11/24/1986
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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