Panels › Hematology › Product code JOX · Class 2
Analyzer, Heparin, Automated
Regulation 864.5680
0510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in JOX
| Company | 510(k)s | Recalls |
|---|---|---|
| Hemotec, Inc. | 5 | 0 |
| Medtronic, Inc. | 3 | 1 |
| Medtronic Vascular | 2 | 0 |
| Cardiovascular Diagnostics, Inc. | 1 | 0 |
| Diagnostica Stago, Inc. | 0 | 1 |
| Hemotech, Inc. | 1 | 0 |
| Medtronic Hemotec, Inc. | 1 | 0 |
| Medtronic Perfusion Systems | 1 | 0 |
| Streck Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2010 | Medtronic Inc Medtronic HMS PLUS, Hemostasis Management System, Model 30514.
It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use ca Terminated |
JOX | K894317 |
| Jul 20, 2004 | Diagnostica Stago, Inc. STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for th Terminated |
JOX | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.