The following data is part of a premarket notification filed by Gen Trak, Inc. with the FDA for Cd8 Monoclonal Antibodies.
| Device ID | K914847 |
| 510k Number | K914847 |
| Device Name: | CD8 MONOCLONAL ANTIBODIES |
| Classification | Assay, T Lymphocyte Surface Marker |
| Applicant | GEN TRAK, INC. 5100 CAMPUS DR. Plymouth Meeting, PA 19462 |
| Contact | Deborah L.lindmouth |
| Correspondent | Deborah L.lindmouth GEN TRAK, INC. 5100 CAMPUS DR. Plymouth Meeting, PA 19462 |
| Product Code | LIZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-28 |
| Decision Date | 1992-06-19 |