510(k) K083878
- Device
- LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
- Applicant
- R2 DIAGNOSTICS, INC.
- 510(k) number
- K083878
- Product code
- GIR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-06-25
- Date received
- 2008-12-29
- Regulation
- 864.8950
- Classification name
- Reagent, Russel Viper Venom
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARC D GOLDFORD
- Address
- 1801 Commerce Dr. South Bend IN US 46628 46628
FDA Registration Numbers#
- 9710666
- 2432235
- 3004737529
- 3003691680
- 2431530
- 8043599
- 3003601075
- 3037000637
- 9610806
- 1835316
- 2245451
- 3008386529
Source Documents#
Other 510(k) Records For Product Code GIR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Dsrv, Inc. | 2014-01-10 |
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Dsrv, Inc. | 2014-01-10 |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Instrumentation Laboratory CO | 2011-08-24 |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | 2006-12-06 |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Sigma Diagnostics, Inc. | 2000-04-07 |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Sigma Diagnostics, Inc. | 2000-04-07 |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | Precision Biologic | 1999-07-28 |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | Precision Biologic | 1999-07-23 |
| K990302 | IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) | Instrumentation Laboratory CO | 1999-04-08 |
| K940490 | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | 1995-04-05 |
| K932463 | BIOCLOT LA | Biopool AB | 1993-09-27 |
| K922156 | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | 1993-04-06 |
| K922326 | LUPO-TEST REGEANT | Graoipore , Ltd. | 1993-04-06 |
| K903037 | LUPO-TEST REAGENT | Gradipore , Ltd. | 1990-12-17 |
| K841365 | DIA REPTIN | Diatech, Inc. | 1984-06-01 |
Legacy Summary#
summary
FDA Review#
Decision Summary