510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102993Substantially Equivalent

Elitech Clinical Systems Triglycerides Sl, Elitech Clinical Systems Cholesterol Sl

VitalScientific, Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102993 is the FDA 510(k) clearance record for ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL, a class I device, cleared for Seppim S.A.S. on under FDA product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides). FDA records list 11 510(k) clearances for VitalScientific, from to . As of , FDA records show no recalls naming K102993.

Clearance record

Decision date
Received
(223 days to decision)
Product code
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Seppim S.A.S. 21720 23rd Dr. SE Suite 150, Bothell WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CDT

Trailing 12 months

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

FDA records show no clearances under product code CDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDT, 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