The following data is part of a premarket notification filed by Genus Diagnostics with the FDA for Wi-38 Gencells.
| Device ID | K851561 |
| 510k Number | K851561 |
| Device Name: | WI-38 GENCELLS |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
| Contact | Peter J Mione |
| Correspondent | Peter J Mione GENUS DIAGNOSTICS 225 WILDWOOD ST. Woburn, MA 01801 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-05-10 |