FDA 510(k) Application Details - K884498

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K884498
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES, CA US
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Contact FRANK MATARRESE
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 10/26/1988
Decision Date 12/22/1988
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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