Cleared Traditional

LUPO-TEST REAGENT

K903037 · Gradipore , Ltd. · Hematology
Dec 1990
Decision
159d
Days
Class 1
Risk

About This 510(k) Submission

K903037 is an FDA 510(k) clearance for the LUPO-TEST REAGENT, a Reagent, Russel Viper Venom (Class I — General Controls, product code GIR), submitted by Gradipore , Ltd. (Pyrmont, AU). The FDA issued a Cleared decision on December 17, 1990, 159 days after receiving the submission on July 11, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.

Submission Details

510(k) Number K903037 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 1990
Decision Date December 17, 1990
Days to Decision 159 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIR — Reagent, Russel Viper Venom
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8950

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