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FDA 510(k) Application Details - K964442
Device Classification Name
Enzyme Immunoassay, Valproic Acid
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510(K) Number
K964442
Device Name
Enzyme Immunoassay, Valproic Acid
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact
GABRIEL J MURACA, JR.
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Regulation Number
862.3645
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Classification Product Code
LEG
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More FDA Info for this Product Code
Date Received
11/06/1996
Decision Date
12/18/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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