← Product Code [GKQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKQ) · K823520

# FIBROSYSTEM (K823520)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · GKQ · Dec 28, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKQ/K823520

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [GKQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKQ.md)
- **Decision Date:** Dec 28, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7900
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKQ/K823520](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKQ/K823520)

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