Atlas FDA

GIR

16 FDA 510(k) clearances · Product code

162 daysmedian time to decision
426 days90th percentile
16clearances measured

FDA profile

Official device name
Reagent, Russel Viper Venom
Device class
Class I (low risk)
Regulation
21 CFR 864.8950
Medical specialty
Hematology
Flags
Third-party review eligible
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RecordFirmDate
REAGENT, RUSSEL VIPER VENOM - LA CONFIRM (K132076)Dsrv, Inc.2014-01-10
REAGENT, RUSSEL VIPER VENOM - LA SCREEN (K132130)Dsrv, Inc.2014-01-10
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031)Instrumentation Laboratory CO2011-08-24
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA (K083878)R2 Diagnostics, Inc.2010-06-25
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM (K061805)Diagnostica Stago, Inc.2006-12-06
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 (K000528)Sigma Diagnostics, Inc.2000-04-07
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 (K000527)Sigma Diagnostics, Inc.2000-04-07
CRYOCHECK LA SURE, MODEL SUR25-10 (K990580)Precision Biologic1999-07-28
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) (K990579)Precision Biologic1999-07-23
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) (K990302)Instrumentation Laboratory CO1999-04-08
DV TEST AND DVV CONFIRM (K940490)American Diagnostica, Inc.1995-04-05
BIOCLOT LA (K932463)Biopool AB1993-09-27
LUPO-TEST REGEANT (K922326)Graoipore , Ltd.1993-04-06
LUCOR CONFIRMATORY REAGENT (K922156)Gradipore , Ltd.1993-04-06
LUPO-TEST REAGENT (K903037)Gradipore , Ltd.1990-12-17
DIA REPTIN (K841365)Diatech, Inc.1984-06-01

Track GIR automatically

Every clearance here is in the API, with alerts when new ones post.