FDA 510(k) Applications for Medical Device Product Code "GIR"
(Reagent, Russel Viper Venom)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061805 | DIAGNOSTICA STAGO, INC. | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | 12/06/2006 |
| K132076 | DSRV, INC. | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | 01/10/2014 |
| K132130 | DSRV, INC. | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | 01/10/2014 |
| K110031 | INSTRUMENTATION LABORATORY CO. | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | 08/24/2011 |
| K990302 | INSTRUMENTATION LABORATORY CO. | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) | 04/08/1999 |
| K990579 | PRECISION BIOLOGIC | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | 07/23/1999 |
| K990580 | PRECISION BIOLOGIC | CRYOCHECK LA SURE, MODEL SUR25-10 | 07/28/1999 |
| K083878 | R2 DIAGNOSTICS, INC. | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | 06/25/2010 |
| K000528 | SIGMA DIAGNOSTICS, INC. | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | 04/07/2000 |
| K000527 | SIGMA DIAGNOSTICS, INC. | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | 04/07/2000 |
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