JPE — Antithrombin Iii, Two Stage Clotting Time Assay Class II
FDA product code JPE covers "Antithrombin Iii, Two Stage Clotting Time Assay", a Class II medical device regulated under 21 CFR 864.7060. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- JPE
- Device Class
- Class II
- Regulation Number
- 864.7060
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K933125 | behring diagnostics | BERICHROM ANTITHROMBIN III (A) | April 19, 1994 |