← Product Code [JOX](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX) · K830665

# HEPCOL SYSTEM B-10 & B-10-P (K830665)

_Hemotec, Inc. · JOX · Jun 8, 1983 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K830665

## Device Facts

- **Applicant:** Hemotec, Inc.
- **Product Code:** [JOX](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX.md)
- **Decision Date:** Jun 8, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5680
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

## Special Controls

*Classification.* Class II (special controls).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K830665](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOX/K830665)

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