The following data is part of a premarket notification filed by Neogenex with the FDA for Hep-2 Culture Cell.
| Device ID | K933927 |
| 510k Number | K933927 |
| Device Name: | HEP-2 CULTURE CELL |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Contact | E. William Radany |
| Correspondent | E. William Radany NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-10 |
| Decision Date | 1994-03-31 |