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) → GIE — Fibrometer

# GIE · Fibrometer

_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/GIE

## Overview

- **Product Code:** GIE
- **Device Name:** Fibrometer
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K820533](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIE/K820533.md) | B4182-1 | American Scientific Products | Apr 8, 1982 | SESE |
| [K820532](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GIE/K820532.md) | DISPO FIBRIN PIPET TIPS B4182-2 | American Scientific Products | Apr 8, 1982 | SESE |

## Top Applicants

- American Scientific Products — 2 clearances

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

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