FDA 510(k) Application Details - K893605

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K893605
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant SERONO-BAKER DIAGNOSTICS, INC.
100 CASCADE DR.
ALLENTOWN, PA US
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Contact TOMALESKY
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 05/10/1989
Decision Date 06/20/1989
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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