FDA 510(k) Application Details - K863053

Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt

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510(K) Number K863053
Device Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
Applicant J. D. ASSOC.
163 MONTCLAIR AVE.
MONTCLAIR, NJ US
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Contact DI PIETRO
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Regulation Number 862.1030

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Classification Product Code CKA
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Date Received 08/12/1986
Decision Date 12/10/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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