FDA 510(k) Application Details - K840706

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

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510(K) Number K840706
Device Name Nadh Oxidation/Nad Reduction, Ast/Sgot
Applicant AMERICAN DADE

, US
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Regulation Number 862.1100

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Classification Product Code CIT
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Date Received 02/17/1984
Decision Date 04/04/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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