510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870363Substantially Equivalent

Haemoglobin Reagent - Cyanmethaemoglobin Method

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

K870363 is the FDA 510(k) clearance record for HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD, a class II device, cleared for Trace Scientific , Ltd. on under FDA product code KHG (Whole Blood Hemoglobin Determination). FDA records list 55 510(k) clearances for Trace Scientific , Ltd., from to . As of , FDA records show no recalls naming K870363.

Clearance record

Decision date
Received
(47 days to decision)
Product code
KHG Whole Blood Hemoglobin Determination
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Trace Scientific , Ltd. 10 Treforest Dr., Clayton, Vic 3168, AU
Third party review
No

Clearances, product code KHG

Trailing 12 months

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

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