Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5400](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5400) → JBT — Timer, Coagulation

# JBT · Timer, Coagulation

_Hematology · 21 CFR 864.5400 · Class 2_

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

## Overview

- **Product Code:** JBT
- **Device Name:** Timer, Coagulation
- **Regulation:** [21 CFR 864.5400](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5400)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

## Classification Rationale

Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Special Controls

*Classification.* Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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