Instrument, Coagulation
This device is a coagulation instrument, a laboratory analyzer used to perform coagulation tests such as prothrombin time (PT), activated partial thromboplastin time (aPTT), and other clotting factor assays, supporting the diagnosis and management of bleeding and clotting disorders. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KQG, regulated under 21 CFR 864.5400 within the Hematology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KQG
- Device Class
- FDA class 2
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050821 | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM | Aug 16, 2005 | Substantially Equivalent | Zycare |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Oct 25, 2002 | Substantially Equivalent | Vital Scientific N.V. |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Sep 03, 1999 | Substantially Equivalent | Pacific Hemostasis |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Jun 21, 1999 | Substantially Equivalent | Pacific Hemostasis |
| K983475 | HEMOCHRON RESPONSE | May 03, 1999 | Substantially Equivalent | International Technidyne Corp. |
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Nov 08, 1990 | Substantially Equivalent | Logos Scientific, Inc. |
| K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | Apr 16, 1990 | Substantially Equivalent | Texas Intl. Laboratories, Inc. |
| K862047 | COAGULATOR (8 CHANNEL) | Sep 29, 1986 | Substantially Equivalent | Med USA |
| K852492 | COAGULATOR | Aug 13, 1985 | Substantially Equivalent | Med USA |
| K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER | Jun 24, 1985 | Substantially Equivalent | Medical Laboratory Automation Systems, Inc. |
| K823131 | KOAGULAB 40-A AUTOMATED COAGULATION SYS | Dec 09, 1982 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K812906 | ELVI BICLOT 816 | Jul 22, 1982 | Substantially Equivalent | Volu Sol Medical Industries |
| K791587 | ELVI 810 CLOTSCANNER | Sep 17, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
| K770914 | INCUBATOR, PORTABLE, ACT-STAT | Aug 04, 1977 | Substantially Equivalent | Thermolyne Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.