Lupo-Test Reagent

FDA 510(k) K903037 · Gradipore , Ltd.

Substantially Equivalent

510(k) numberK903037

Submission

Device name
Lupo-Test Reagent
Applicant
Gradipore , Ltd.
Pyrmont, AU
Received
July 11, 1990
Decision date
December 17, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code GIR

510(k)DeviceApplicantDecision
K132130Reagent, Russel Viper Venom - la ScreenGIR · Special Dsrv, Inc.01/10/2014SE
K132076Reagent, Russel Viper Venom - la ConfirmGIR · Special Dsrv, Inc.01/10/2014SE
K110031Hemosil Drvvt Screen & Hemosil Drvvt ConfirmGIR · Traditional Instrumentation Laboratory CO08/24/2011SE
K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon laGIR · Traditional R2 Diagnostics, Inc.06/25/2010SE
K061805Sta - Staclot DRVV Screen; Sta - Staclot DRVV ConfirmGIR · Traditional Diagnostica Stago, Inc.12/06/2006SE
K000528Accuclot Drvvt Confirm, Catalog No. A62119GIR · Traditional Sigma Diagnostics, Inc.04/07/2000SE
K000527Accuclot Drvvt Screen, Catalog No. A6094GIR · Traditional Sigma Diagnostics, Inc.04/07/2000SE
K990580Cryocheck la Sure, Model SUR25-10GIR · Traditional Precision Biologic07/28/1999SE
K990579Cryocheck la Check, Models CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIR · Traditional Precision Biologic07/23/1999SE
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

510(k)DeviceDecision
K993332Gradiplasma la High, Gradiplasma la Low Models LAHP-1, LAHP-05, LALP-1, LALP-05GGC · Traditional 02/16/2000SE
K992456Gradileiden V TestGGW · Traditional 12/21/1999SE
K922156Lucor Confirmatory ReagentGIR · Traditional 04/06/1993SE

Questions and answers

When was Lupo-Test Reagent cleared by the FDA?

Lupo-Test Reagent (K903037) received a 510(k) decision of Substantially Equivalent on December 17, 1990, 159 days after the submission was received.

What is the product code of K903037?

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