FDA 510(k) Application Details - K953063

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K953063
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant QUIDEL CORP.
10165 MCKELLAR COURT
SAN DIEGO, CA US
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Contact ROBIN WEINER
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 06/30/1995
Decision Date 08/23/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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