JCA — Device, Bleeding Time Class II
FDA product code JCA covers "Device, Bleeding Time", a Class II medical device regulated under 21 CFR 864.6100. Submissions are reviewed by the Hematology panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JCA
- Device Class
- Class II
- Regulation Number
- 864.6100
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K911745 | organon teknika | SIMPLATE PEDIATRIC | August 9, 1991 |
| K911996 | international technidyne | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | July 17, 1991 |
| K871318 | helena laboratories | Q.I.C. BLEEDING TIME DEVICE | June 10, 1987 |
| K850542 | international technidyne | SURGICUTT - BLEEDING TIME DEVICE | March 1, 1985 |
| K830645 | american dade | BLEEDING TIME DEVICE DISPOSABLE | March 17, 1983 |
| K801815 | ulster scientific | AUTOLET | October 10, 1980 |
| K761250 | general diagnostics | SIMPLATE | March 1, 1977 |