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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name glucose oxidase, glucose
510(k) Number K100525
Device Name ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2
Applicant
SEPPIM S.A.S.
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Applicant Contact Debra Hutson
Correspondent
SEPPIM S.A.S.
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Correspondent Contact Debra Hutson
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Codes
JIX   JJX  
Date Received02/24/2010
Decision Date 12/15/2010
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
Recalls CDRH Recalls
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