FDA 510(k) Application Details - K000005

Device Classification Name Enzyme Immunoassay, Valproic Acid

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510(K) Number K000005
Device Name Enzyme Immunoassay, Valproic Acid
Applicant DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES, CA 90045-5597 US
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Contact EDWARD M LEVINE
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Regulation Number 862.3645

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Classification Product Code LEG
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Date Received 01/03/2000
Decision Date 03/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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