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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K111996
Device Name ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
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 Number862.1660
Classification Product Code
JJY  
Date Received07/13/2011
Decision Date 09/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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