LUCOR CONFIRMATORY REAGENT
Device Facts
| Record ID | K922156 |
|---|---|
| Device Name | LUCOR CONFIRMATORY REAGENT |
| Applicant | Gradipore , Ltd. |
| Product Code | GIR · Hematology |
| Decision Date | Apr 6, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8950 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.