Dna-Probe, B And T Lymphocyte
FDA product code MAM · Class II (moderate risk) · 21 CFR 864.5220 · Hematology
1510(k) clearances
1PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923951 | CD8 Cytospheres KitMAM · Traditional | Coulter Electronics, Inc. | 04/25/1994SE |
PMA approvals
- P880016 Oncor B/T Gene Rearrangement Test · Oncor, Inc. · 10/10/1989