KQG · Instrument, Coagulation
Hematology · 21 CFR 864.5400 · Class 2
Overview
| Product Code | KQG |
|---|---|
| Device Name | Instrument, Coagulation |
| Regulation | 21 CFR 864.5400 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 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 | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM | Zycare | Aug 16, 2005 | SESE |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Vital Scientific N.V. | Oct 25, 2002 | SESE |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Pacific Hemostasis | Sep 3, 1999 | SESE |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Pacific Hemostasis | Jun 21, 1999 | SESE |
| K983475 | HEMOCHRON RESPONSE | International Technidyne Corp. | May 3, 1999 | SESE |
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Logos Scientific, Inc. | Nov 8, 1990 | SESE |
| K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | Texas Intl. Laboratories, Inc. | Apr 16, 1990 | SESE |
| K862047 | COAGULATOR (8 CHANNEL) | Med USA | Sep 29, 1986 | SESE |
| K852492 | COAGULATOR | Med USA | Aug 13, 1985 | SESE |
| K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | Jun 24, 1985 | SESE |
| K823131 | KOAGULAB 40-A AUTOMATED COAGULATION SYS | Ortho Diagnostic Systems, Inc. | Dec 9, 1982 | SESE |
| K812906 | ELVI BICLOT 816 | Volu Sol Medical Industries | Jul 22, 1982 | SESE |
| K791587 | ELVI 810 CLOTSCANNER | Volu Sol Medical Industries | Sep 17, 1979 | SESE |
| K770914 | 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
