FDA 510(k) Application Details - K920160

Device Classification Name Radioimmunoassay, Luteinizing Hormone

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510(K) Number K920160
Device Name Radioimmunoassay, Luteinizing Hormone
Applicant QUIDEL CORP.
10165 MCKELLAR COURT
SAN DIEGO, CA US
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Contact JOHN D TAMERIUS
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Regulation Number 862.1485

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Classification Product Code CEP
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Date Received 01/14/1992
Decision Date 03/11/1992
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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