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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl
510(k) Number K103747
Device Name ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
Applicant
ELITECHGROUP SEPPIM S.A.S.
21720 23RD DR SE, SUITE 150
BOTHELL,  WA  98021
Applicant Contact DEBRA K HUTSON
Correspondent
ELITECHGROUP SEPPIM S.A.S.
21720 23RD DR SE, SUITE 150
BOTHELL,  WA  98021
Correspondent Contact DEBRA K HUTSON
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Codes
JIT   JJY   MRR  
Date Received12/23/2010
Decision Date 08/31/2011
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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