Device, Bleeding Time
FDA product code JCA · Class II (moderate risk) · 21 CFR 864.6100 · Hematology
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911745 | Simplate PediatricJCA · Traditional | Organon Teknika Corp. | 08/09/1991SE |
| K911996 | Surgicutt-Bleeding Time Device, ModificationJCA · Traditional | International Technidyne Corp. | 07/17/1991SE |
| K871318 | Q.I.C. Bleeding Time DeviceJCA · Traditional | Helena Laboratories | 06/10/1987SE |
| K850542 | Surgicutt - Bleeding Time DeviceJCA · Traditional | International Technidyne Corp. | 03/01/1985SE |
| K830645 | Bleeding Time Device DisposableJCA · Traditional | American Dade | 03/17/1983SE |
| K801815 | AutoletJCA · Traditional | Ulster Scientific, Inc. | 10/10/1980SE |
| K761250 | SimplateJCA · Traditional | General Diagnostics | 03/01/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0137-2014 Class II | Surgicutt fully automated incision making device for bleeding time determination. ITC 8…ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M)… | ITC-Nexus Dx | 08/22/2013Terminated |