KQG — Instrument, Coagulation Class II
FDA product code KQG covers "Instrument, Coagulation", a Class II medical device regulated under 21 CFR 864.5400. Submissions are reviewed by the Hematology panel. At least 14 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KQG
- Device Class
- Class II
- Regulation Number
- 864.5400
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K050821 | zycare | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM | August 16, 2005 |
| K021976 | vital scientific n.v | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | October 25, 2002 |
| K992130 | pacific hemostasis | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | September 3, 1999 |
| K991321 | pacific hemostasis | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | June 21, 1999 |
| K983475 | international technidyne | HEMOCHRON RESPONSE | May 3, 1999 |
| K902614 | logos scientific | ELVI 828 DIGICLOT MULTISCAN | November 8, 1990 |
| K900685 | texas intl. laboratories | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | April 16, 1990 |
| K862047 | med usa | COAGULATOR (8 CHANNEL) | September 29, 1986 |
| K852492 | med usa | COAGULATOR | August 13, 1985 |
| K851169 | medical laboratory automation systems | ELECTRA 800 AUTOMATIC COAGULATION TIMER | June 24, 1985 |
| K823131 | ortho diagnostic systems | KOAGULAB 40-A AUTOMATED COAGULATION SYS | December 9, 1982 |
| K812906 | volu sol medical industries | ELVI BICLOT 816 | July 22, 1982 |
| K791587 | volu sol medical industries | ELVI 810 CLOTSCANNER | September 17, 1979 |
| K770914 | thermolyne | INCUBATOR, PORTABLE, ACT-STAT | August 4, 1977 |