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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nitrophenylphosphate, alkaline phosphatase or isoenzymes
510(k) Number K113269
Device Name ELITTECH CLINICAL SYSTEMS ALP IFCC SL
Applicant
ELITECHGROUP
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
ELITECHGROUP
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1050
Classification Product Code
CJE  
Date Received11/04/2011
Decision Date 12/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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