← Product Code [JBQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ) · K000361

# K-ASSAY AT-III (K000361)

_Kamiya Biomedical Co. · JBQ · Apr 26, 2000 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K000361

## Device Facts

- **Applicant:** Kamiya Biomedical Co.
- **Product Code:** [JBQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ.md)
- **Decision Date:** Apr 26, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7060
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K000361](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K000361)

**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