FDA Product Code
FDA Product Code KQG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5400
510(k) Clearances — 14 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050821 | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM | Zycare | 2005-08-16 | Traditional | PDF ↗ |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Vital Scientific N.V. | 2002-10-25 | Traditional | PDF ↗ |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | Pacific Hemostasis | 1999-09-03 | Traditional | PDF ↗ |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | Pacific Hemostasis | 1999-06-21 | Traditional | PDF ↗ |
| K983475 | HEMOCHRON RESPONSE | International Technidyne Corp. | 1999-05-03 | Traditional | PDF ↗ |
| K902614 | ELVI 828 DIGICLOT MULTISCAN | Logos Scientific, Inc. | 1990-11-08 | Traditional | PDF ↗ |
| K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER | Texas Intl. Laboratories, Inc. | 1990-04-16 | Traditional | PDF ↗ |
| K862047 | COAGULATOR (8 CHANNEL) | Med USA | 1986-09-29 | Traditional | PDF ↗ |
| K852492 | COAGULATOR | Med USA | 1985-08-13 | Traditional | PDF ↗ |
| K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1985-06-24 | Traditional | PDF ↗ |
| K823131 | KOAGULAB 40-A AUTOMATED COAGULATION SYS | Ortho Diagnostic Systems, Inc. | 1982-12-09 | Traditional | PDF ↗ |
| K812906 | ELVI BICLOT 816 | Volu Sol Medical Industries | 1982-07-22 | Traditional | PDF ↗ |
| K791587 | ELVI 810 CLOTSCANNER | Volu Sol Medical Industries | 1979-09-17 | Traditional | PDF ↗ |
| K770914 | INCUBATOR, PORTABLE, ACT-STAT | Thermolyne Corp. | 1977-08-04 | Traditional | PDF ↗ |
Product code KQG · Class II · Hematology. Data: openFDA.