510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904116Substantially Equivalent

Iron 5 X Conc Reagent

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

K904116 is the FDA 510(k) clearance record for IRON 5 X CONC REAGENT, a class I device, cleared for Trace Scientific , Ltd. on under FDA product code JMO (Ferrozine (Colorimetric) Iron Binding Capacity). FDA records list 55 510(k) clearances for Trace Scientific , Ltd., from to . As of , FDA records show no recalls naming K904116.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JMO Ferrozine (Colorimetric) Iron Binding Capacity
Regulation
21 CFR 862.1415
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Trace Scientific , Ltd. 10 Treforest Dr., Clayton, Vic 3168, AU
Third party review
No

Clearances, product code JMO

Trailing 12 months

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

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