← Product Code [GJB](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJB) · K820084

# CLOTTING TIME REAGENT (K820084)

_American Dade · GJB · Feb 22, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJB/K820084

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [GJB](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJB.md)
- **Decision Date:** Feb 22, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7875
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJB/K820084](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJB/K820084)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com