Cleared Traditional

LUCOR CONFIRMATORY REAGENT

K922156 · Gradipore , Ltd. · Hematology
Apr 1993
Decision
334d
Days
Class 1
Risk

About This 510(k) Submission

K922156 is an FDA 510(k) clearance for the LUCOR CONFIRMATORY 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 April 6, 1993, 334 days after receiving the submission on May 7, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8950.

Submission Details

510(k) Number K922156 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1992
Decision Date April 06, 1993
Days to Decision 334 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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