510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K792555Substantially Equivalent

Elvi Non-Esterified Fatty Acids

Volu Sol Medical Industries, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K792555 is the FDA 510(k) clearance record for ELVI NON-ESTERIFIED FATTY ACIDS, a class I device, cleared for Volu Sol Medical Industries on under FDA product code JLH (Titrimetric, Fatty Acids). FDA records list 66 510(k) clearances for Volu Sol Medical Industries, from to . As of , FDA records show no recalls naming K792555.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JLH Titrimetric, Fatty Acids
Regulation
21 CFR 862.1290
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Volu Sol Medical Industries 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JLH

Trailing 12 months

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

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