← Product Code [GIR](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR) · K940490

# DV TEST AND DVV CONFIRM (K940490)

_American Diagnostica, Inc. · GIR · Apr 5, 1995 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K940490

## Device Facts

- **Applicant:** American Diagnostica, Inc.
- **Product Code:** [GIR](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR.md)
- **Decision Date:** Apr 5, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8950
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K940490](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GIR/K940490)

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