The following data is part of a premarket notification filed by Neogenex with the FDA for Influenza A Antigen Test.
| Device ID | K942172 |
| 510k Number | K942172 |
| Device Name: | INFLUENZA A ANTIGEN TEST |
| Classification | Antisera, Cf, Influenza Virus A, B, C |
| Applicant | NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Contact | D.f. Roberts |
| Correspondent | D.f. Roberts NEOGENEX 12811 EIGHT AVENUE WEST SUITE A-101 Everett, WA 98204 |
| Product Code | GNW |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-05 |
| Decision Date | 1994-07-06 |