Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7900](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7900) → GKQ — Test, Thromboplastin Generation

# GKQ · Test, Thromboplastin Generation

_Hematology · 21 CFR 864.7900 · Class 1_

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

## Overview

- **Product Code:** GKQ
- **Device Name:** Test, Thromboplastin Generation
- **Regulation:** [21 CFR 864.7900](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7900)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

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

## Classification Rationale

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823520](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKQ/K823520.md) | FIBROSYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Dec 28, 1982 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance

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

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