510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870365Substantially Equivalent

Direct Bilirubin Reagent - Acid Diazo Method

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

K870365 is the FDA 510(k) clearance record for DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD, a class II device, cleared for Trace Scientific , Ltd. on under FDA product code CIG (Diazo Colorimetry, Bilirubin). FDA records list 55 510(k) clearances for Trace Scientific , Ltd., from to . As of , FDA records show no recalls naming K870365.

Clearance record

Decision date
Received
(203 days to decision)
Product code
CIG Diazo Colorimetry, Bilirubin
Regulation
21 CFR 862.1110
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 CIG

Trailing 12 months
1 clearance under product code CIG 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 CIG, 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