FDA Product Code
FDA Product Code GIR — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8950
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132076 | REAGENT, RUSSEL VIPER VENOM - LA CONFIRM | Dsrv, Inc. | 2014-01-10 | Special | PDF ↗ |
| K132130 | REAGENT, RUSSEL VIPER VENOM - LA SCREEN | Dsrv, Inc. | 2014-01-10 | Special | PDF ↗ |
| K110031 | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM | Instrumentation Laboratory CO | 2011-08-24 | Traditional | PDF ↗ |
| K083878 | LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA | R2 Diagnostics, Inc. | 2010-06-25 | Traditional | PDF ↗ |
| K061805 | STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM | Diagnostica Stago, Inc. | 2006-12-06 | Traditional | PDF ↗ |
| K000527 | ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 | Sigma Diagnostics, Inc. | 2000-04-07 | Traditional | PDF ↗ |
| K000528 | ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 | Sigma Diagnostics, Inc. | 2000-04-07 | Traditional | PDF ↗ |
| K990580 | CRYOCHECK LA SURE, MODEL SUR25-10 | Precision Biologic | 1999-07-28 | Traditional | PDF ↗ |
| K990579 | CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML) | Precision Biologic | 1999-07-23 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K940490 | DV TEST AND DVV CONFIRM | American Diagnostica, Inc. | 1995-04-05 | Traditional | PDF ↗ |
| K932463 | BIOCLOT LA | Biopool AB | 1993-09-27 | Traditional | PDF ↗ |
| K922326 | LUPO-TEST REGEANT | Graoipore , Ltd. | 1993-04-06 | Traditional | PDF ↗ |
| K922156 | LUCOR CONFIRMATORY REAGENT | Gradipore , Ltd. | 1993-04-06 | Traditional | PDF ↗ |
| K903037 | LUPO-TEST REAGENT | Gradipore , Ltd. | 1990-12-17 | Traditional | PDF ↗ |
| K841365 | DIA REPTIN | Diatech, Inc. | 1984-06-01 | Traditional | PDF ↗ |
Product code GIR · Class I · Hematology. Data: openFDA.