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) → KQG — Instrument, Coagulation

# KQG · Instrument, 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/KQG

## Overview

- **Product Code:** KQG
- **Device Name:** Instrument, 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)
- **3rd-party reviewable:** yes

## 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 (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K050821](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K050821.md) | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM | Zycare | Aug 16, 2005 | SESE |
| [K021976](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K021976.md) | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Vital Scientific N.V. | Oct 25, 2002 | SESE |
| [K992130](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K992130.md) | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Pacific Hemostasis | Sep 3, 1999 | SESE |
| [K991321](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K991321.md) | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Pacific Hemostasis | Jun 21, 1999 | SESE |
| [K983475](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K983475.md) | HEMOCHRON RESPONSE | International Technidyne Corp. | May 3, 1999 | SESE |
| [K902614](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K902614.md) | ELVI 828 DIGICLOT MULTISCAN | Logos Scientific, Inc. | Nov 8, 1990 | SESE |
| [K900685](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K900685.md) | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | Texas Intl. Laboratories, Inc. | Apr 16, 1990 | SESE |
| [K862047](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K862047.md) | COAGULATOR (8 CHANNEL) | Med USA | Sep 29, 1986 | SESE |
| [K852492](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K852492.md) | COAGULATOR | Med USA | Aug 13, 1985 | SESE |
| [K851169](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K851169.md) | ELECTRA 800 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | Jun 24, 1985 | SESE |
| [K823131](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K823131.md) | KOAGULAB 40-A AUTOMATED COAGULATION SYS | Ortho Diagnostic Systems, Inc. | Dec 9, 1982 | SESE |
| [K812906](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K812906.md) | ELVI BICLOT 816 | Volu Sol Medical Industries | Jul 22, 1982 | SESE |
| [K791587](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K791587.md) | ELVI 810 CLOTSCANNER | Volu Sol Medical Industries | Sep 17, 1979 | SESE |
| [K770914](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/KQG/K770914.md) | INCUBATOR, PORTABLE, ACT-STAT | Thermolyne Corp. | Aug 4, 1977 | SESE |

## Top Applicants

- Med USA — 2 clearances
- Pacific Hemostasis — 2 clearances
- Volu Sol Medical Industries — 2 clearances
- International Technidyne Corp. — 1 clearance
- Logos Scientific, Inc. — 1 clearance

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

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