MAM — Dna-Probe, B And T Lymphocyte Class II
FDA product code MAM covers "Dna-Probe, B And T Lymphocyte", a Class II medical device regulated under 21 CFR 864.5220. 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
- MAM
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923951 | coulter electronics | CD8 CYTOSPHERES KIT | April 25, 1994 |