510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103747Substantially Equivalent

Elitech Clincal Systems Cholesterol Hdl Sl 2G, Hdl 2G Calibrator, Ldl Sl 2G, Ldl 2G Calibrator, Elitrol II & Elitech Sys

Elitechgroup Seppim S.A.S., Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103747 is the FDA 510(k) clearance record for ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS, a class I device, cleared for Elitechgroup Seppim S.A.S. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list one 510(k) clearance for Elitechgroup Seppim S.A.S. As of , FDA records show no recalls naming K103747.

Clearance record

Decision date
Received
(251 days to decision)
Product code
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Elitechgroup Seppim S.A.S. 21720 23rd Dr. SE Suite 150, Bothell WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBS

Trailing 12 months

FDA records hold no clearances under product code LBS in the trailing twelve months.

FDA records show no clearances under product code LBS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LBS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260