Panels › Hematology › Product code JCA · Class 2
Device, Bleeding Time
Regulation 864.6100
0510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in JCA
| Company | 510(k)s | Recalls |
|---|---|---|
| International Technidyne Corp. | 2 | 0 |
| American Dade | 1 | 0 |
| General Diagnostics | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| ITC-Nexus Dx | 0 | 1 |
| Organon Teknika Corp. | 1 | 0 |
| Ulster Scientific, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2013 | ITC-Nexus Dx Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation.
The de Terminated |
JCA | None listed |
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