FDA 510(k) Application Details - K992136

Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot

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510(K) Number K992136
Device Name Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN, NY 10591-5097 US
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Contact GABRIEL J MURACA
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Regulation Number 862.1100

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Classification Product Code CIT
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Date Received 06/24/1999
Decision Date 11/09/1999
Decision SESE - SUBST EQUIV
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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