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FDA 510(k) Application Details - K971716
Device Classification Name
Enzyme Immunoassay, Procainamide
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510(K) Number
K971716
Device Name
Enzyme Immunoassay, Procainamide
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
862.3320
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Classification Product Code
LAR
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More FDA Info for this Product Code
Date Received
05/09/1997
Decision Date
06/27/1997
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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