Lucor Confirmatory Reagent

FDA 510(k) K922156 · Gradipore , Ltd.

Substantially Equivalent

510(k) numberK922156

Submission

Device name
Lucor Confirmatory Reagent
Applicant
Gradipore , Ltd.
Pyrmont, AU
Received
May 7, 1992
Decision date
April 6, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GIR – Reagent, Russel Viper Venom
Device class
Class I (low risk)
Regulation
21 CFR 864.8950
Specialty
Hematology

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K000528Accuclot Drvvt Confirm, Catalog No. A62119GIR · Traditional Sigma Diagnostics, Inc.04/07/2000SE
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K990580Cryocheck la Sure, Model SUR25-10GIR · Traditional Precision Biologic07/28/1999SE
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K990302Il Test Lac Screen (Claims Added to Acl Futura), Il Test Lac Confirm (Claims Addad to…GIR · Traditional Instrumentation Laboratory CO04/08/1999SE

More from Instrumentation Laboratory CO

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Questions and answers

When was Lucor Confirmatory Reagent cleared by the FDA?

Lucor Confirmatory Reagent (K922156) received a 510(k) decision of Substantially Equivalent on April 6, 1993, 334 days after the submission was received.

What is the product code of K922156?

The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.