Panels › Hematology › Product code KQG · Class 2
Instrument, Coagulation
Regulation 864.5400
0510(k)s in 12 months (14 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in KQG
| Company | 510(k)s | Recalls |
|---|---|---|
| International Technidyne Corp. | 1 | 1 |
| Med USA | 2 | 0 |
| Pacific Hemostasis | 2 | 0 |
| Volu Sol Medical Industries | 2 | 0 |
| Logos Scientific, Inc. | 1 | 0 |
| Medical Laboratory Automation Systems, Inc. | 1 | 0 |
| Ortho Diagnostic Systems, Inc. | 1 | 0 |
| Texas Intl. Laboratories, Inc. | 1 | 0 |
| Thermolyne Corp. | 1 | 0 |
| Vital Scientific N.V. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 16, 2005 | K050821 | COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM Zycare | KQG |
| Oct 25, 2002 | K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON Vital Scientific N.V. | KQG |
| Sep 3, 1999 | K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C Pacific Hemostasis | KQG |
| Jun 21, 1999 | K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 Pacific Hemostasis | KQG |
| May 3, 1999 | K983475 | HEMOCHRON RESPONSE International Technidyne Corp. | KQG |
| Nov 8, 1990 | K902614 | ELVI 828 DIGICLOT MULTISCAN Logos Scientific, Inc. | KQG |
| Apr 16, 1990 | K900685 | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER Texas Intl. Laboratories, Inc. | KQG |
| Sep 29, 1986 | K862047 | COAGULATOR (8 CHANNEL) Med USA | KQG |
| Aug 13, 1985 | K852492 | COAGULATOR Med USA | KQG |
| Jun 24, 1985 | K851169 | ELECTRA 800 AUTOMATIC COAGULATION TIMER Medical Laboratory Automation Systems, Inc. | KQG |
| Dec 9, 1982 | K823131 | KOAGULAB 40-A AUTOMATED COAGULATION SYS Ortho Diagnostic Systems, Inc. | KQG |
| Jul 22, 1982 | K812906 | ELVI BICLOT 816 Volu Sol Medical Industries | KQG |
| Sep 17, 1979 | K791587 | ELVI 810 CLOTSCANNER Volu Sol Medical Industries | KQG |
| Aug 4, 1977 | K770914 | INCUBATOR, PORTABLE, ACT-STAT Thermolyne Corp. | KQG |
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