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FDA 510(k) Application Details - K974833
Device Classification Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
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510(K) Number
K974833
Device Name
Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Applicant
INTERSECT SYSTEMS, INC.
P.O. BOX 2219
LONGVIEW, WA 98632 US
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Contact
MARK E LEGAZ
Other 510(k) Applications for this Contact
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
12/24/1997
Decision Date
02/13/1998
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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