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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K100263
Device Name ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTS
Applicant
SEPPIM S.A.S.
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
SEPPIM S.A.S.
21720 23RD DR SE
SUITE 150
BOTHELL,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1580
Classification Product Code
CEO  
Subsequent Product Codes
CDQ   JIX   JJY   KNK  
Date Received01/28/2010
Decision Date 05/06/2011
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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