GIR · Class I · 21 CFR 864.8950

FDA Product Code GIR: Reagent, Russel Viper Venom

Leading manufacturers include Gradipore , Ltd., Precision Biologic and Sigma Diagnostics, Inc..

16
Total
16
Cleared
201d
Avg days
1984
Since

FDA 510(k) Cleared Reagent, Russel Viper Venom Devices (Product Code GIR)

16 devices
1–16 of 16
Cleared Jan 10, 2014
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM
K132076
Dsrv, Inc.
Hematology · 191d
Cleared Jan 10, 2014
REAGENT, RUSSEL VIPER VENOM - LA SCREEN
K132130
Dsrv, Inc.
Hematology · 184d
Cleared Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
K110031
Instrumentation Laboratory CO
Hematology · 231d
Cleared Jun 25, 2010
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
K083878
R2 Diagnostics, Inc.
Hematology · 543d
Cleared Dec 06, 2006
STA - STACLOT DRVV SCREEN
K061805
Diagnostica Stago, Inc.
Hematology · 162d
Cleared Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
K000527
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
K000528
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
K990580
Precision Biologic
Hematology · 155d
Cleared Jul 23, 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
K990579
Precision Biologic
Hematology · 150d
Cleared Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
K990302
Instrumentation Laboratory CO
Hematology · 66d
Cleared Apr 05, 1995
DV TEST AND DVV CONFIRM
K940490
American Diagnostica, Inc.
Hematology · 426d
Cleared Sep 27, 1993
BIOCLOT LA
K932463
Biopool AB
Hematology · 129d
Cleared Apr 06, 1993
LUCOR CONFIRMATORY REAGENT
K922156
Gradipore , Ltd.
Hematology · 334d
Cleared Apr 06, 1993
LUPO-TEST REGEANT
K922326
Graoipore , Ltd.
Hematology · 330d
Cleared Dec 17, 1990
LUPO-TEST REAGENT
K903037
Gradipore , Ltd.
Hematology · 159d
Cleared Jun 01, 1984
DIA REPTIN
K841365
Diatech, Inc.
Hematology · 60d

About Product Code GIR - Regulatory Context