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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
510(k) Number K974833
Device Name CK-NAC REAGENT
Applicant
Intersect Systems, Inc.
P.O. Box 2219
Longview,  WA  98632
Applicant Contact MARK E LEGAZ
Correspondent
Intersect Systems, Inc.
P.O. Box 2219
Longview,  WA  98632
Correspondent Contact MARK E LEGAZ
Regulation Number862.1215
Classification Product Code
CGS  
Date Received12/24/1997
Decision Date 02/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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