← Product Code [JBQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ) · K952515

# COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY (K952515)

_Chromogenix AB · JBQ · Jan 23, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K952515

## Device Facts

- **Applicant:** Chromogenix AB
- **Product Code:** [JBQ](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ.md)
- **Decision Date:** Jan 23, 1996
- **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).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K952515](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBQ/K952515)

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