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 | Aug 9, 1991 |
| K911996 | International Technidyne | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | Jul 17, 1991 |
| K871318 | Helena Laboratories | Q.I.C. BLEEDING TIME DEVICE | Jun 10, 1987 |
| K850542 | International Technidyne | SURGICUTT - BLEEDING TIME DEVICE | Mar 1, 1985 |
| K830645 | American Dade | BLEEDING TIME DEVICE DISPOSABLE | Mar 17, 1983 |
| K801815 | Ulster Scientific | AUTOLET | Oct 10, 1980 |
| K761250 | General Diagnostics | SIMPLATE | Mar 1, 1977 |