The following data is part of a premarket notification filed by Neogenex with the FDA for H292 Cell Culture.
| Device ID | K960909 |
| 510k Number | K960909 |
| Device Name: | H292 CELL CULTURE |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | NEOGENEX 12811 EIGHTH AVE. WEST, #A-102 Everett, WA 98204 |
| Contact | E, William Radany, Ph.d. |
| Correspondent | E, William Radany, Ph.d. NEOGENEX 12811 EIGHTH AVE. WEST, #A-102 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 | 1996-03-05 |
| Decision Date | 1996-05-30 |