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FDA 510(k) Application Details - K992148
Device Classification Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
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510(K) Number
K992148
Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant
MORAX
13805 WATERLOO RD.
CHELSEA, MI 48118 US
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Contact
BOREK JANIK
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Regulation Number
862.1215
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Classification Product Code
CGS
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More FDA Info for this Product Code
Date Received
06/24/1999
Decision Date
12/29/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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