ClearanceBrief
Panels › Hematology › Product code GIR · Class 1

Reagent, Russel Viper Venom

Regulation 864.8950

0510(k)s in 12 months (16 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
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Top companies in GIR

Company510(k)sRecalls
American Diagnostica, Inc.11
Dsrv, Inc.20
Gradipore , Ltd.20
Instrumentation Laboratory CO20
Precision Biologic20
Sigma Diagnostics, Inc.20
Biopool AB10
Diagnostica Stago, Inc.10
Diatech, Inc.10
Graoipore , Ltd.10
Decided510(k)Device and applicantCode
Jan 10, 2014K132130REAGENT, RUSSEL VIPER VENOM - LA SCREEN
Dsrv, Inc.
GIR
Jan 10, 2014K132076REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
Dsrv, Inc.
GIR
Aug 24, 2011K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
Instrumentation Laboratory CO
GIR
Jun 25, 2010K083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
R2 Diagnostics, Inc.
GIR
Dec 6, 2006K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
Diagnostica Stago, Inc.
GIR
Apr 7, 2000K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
Sigma Diagnostics, Inc.
GIR
Apr 7, 2000K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
Sigma Diagnostics, Inc.
GIR
Jul 28, 1999K990580CRYOCHECK LA SURE, MODEL SUR25-10
Precision Biologic, CA
GIR
Jul 23, 1999K990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
Precision Biologic, CA
GIR
Apr 8, 1999K990302IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
Instrumentation Laboratory CO
GIR
Apr 5, 1995K940490DV TEST AND DVV CONFIRM
American Diagnostica, Inc.
GIR
Sep 27, 1993K932463BIOCLOT LA
Biopool AB, CA
GIR
Apr 6, 1993K922326LUPO-TEST REGEANT
Graoipore , Ltd., AU
GIR
Apr 6, 1993K922156LUCOR CONFIRMATORY REAGENT
Gradipore , Ltd., AU
GIR
Dec 17, 1990K903037LUPO-TEST REAGENT
Gradipore , Ltd., AU
GIR
Jun 1, 1984K841365DIA REPTIN
Diatech, Inc.
GIR

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