ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS


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

Correspodent Contact debra k hutson
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Codes
JIT   JJY   MRR  
Date Received 12/23/2010
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