| Device Type ID | 2346 |
| Device Name | Device, Bleeding Time |
| Regulation Description | Bleeding Time Device. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.6100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JCA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2346 |
| Device | Device, Bleeding Time |
| Product Code | JCA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bleeding Time Device. |
| CFR Regulation Number | 864.6100 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 2 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ITC-Nexus Dx | II | Jun-26-2015 |