FDA 510(k) Application Details - K840939

Device Classification Name Enzyme Immunoassay, Primidone

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510(K) Number K840939
Device Name Enzyme Immunoassay, Primidone
Applicant SYVA CO.

, US
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Regulation Number 862.3680

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Classification Product Code DJD
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Date Received 03/05/1984
Decision Date 04/24/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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