Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7875](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7875) → GJB — Thrombin

# GJB · Thrombin

_Hematology · 21 CFR 864.7875 · Class 2_

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

## Overview

- **Product Code:** GJB
- **Device Name:** Thrombin
- **Regulation:** [21 CFR 864.7875](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7875)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K820084](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJB/K820084.md) | CLOTTING TIME REAGENT | American Dade | Feb 22, 1982 | SESE |

## Top Applicants

- American Dade — 1 clearance

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

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