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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name u.v. method, cpk isoenzymes
510(k) Number K122083
Model CKSL-0230
Device Name ELITECH CLINICAL SYSTEMS CK NAC SL
Original Applicant
ELITECHGROUP
21720 23rd dr se
suite 150
bothell,  WA  98021
Original Contact debra k hutson
Regulation Number862.1215
Classification Product Code
JHW  
Subsequent Product Codes
JIX   JJY  
Date Received07/16/2012
Decision Date 08/22/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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