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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2011 | International Technidyne Corp. Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date a Terminated |
KQG | K983475 |
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