← Product Code [JBP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP) · K902081

# CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL (K902081)

_Hemotec, Inc. · JBP · Jul 3, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K902081

## Device Facts

- **Applicant:** Hemotec, Inc.
- **Product Code:** [JBP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP.md)
- **Decision Date:** Jul 3, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7140
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K902081](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBP/K902081)

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