510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K860724Substantially Equivalent

Enzymatic Glucose Reagent (Hexokinase)

Trace Scientific, Ltd., Clayton, Vic 3168, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860724 is the FDA 510(k) clearance record for ENZYMATIC GLUCOSE REAGENT (HEXOKINASE), a class II device, cleared for Trace Scientific , Ltd. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 55 510(k) clearances for Trace Scientific , Ltd., from to . As of , FDA records show no recalls naming K860724.

Clearance record

Decision date
Received
(40 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Trace Scientific , Ltd. 10 Treforest Dr., Clayton, Vic 3168, AU
Third party review
No

Clearances, product code CFR

Trailing 12 months
1 clearance under product code CFR in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260