510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903037Substantially Equivalent

Lupo-Test Reagent

Gradipore, Ltd., Pyrmont, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903037 is the FDA 510(k) clearance record for LUPO-TEST REAGENT, a class I device, cleared for Gradipore , Ltd. on under FDA product code GIR (Reagent, Russel Viper Venom). FDA records list 4 510(k) clearances for Gradipore , Ltd., from to . As of , FDA records show no recalls naming K903037.

Clearance record

Decision date
Received
(159 days to decision)
Product code
GIR Reagent, Russel Viper Venom
Regulation
21 CFR 864.8950
Device class
Class I
Review panel
Hematology
Applicant
Gradipore , Ltd. 200 Harris St., Pyrmont, AU
Third party review
No

Clearances, product code GIR

Trailing 12 months

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

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