The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Influenza Ha Antigen A/ussr.
| Device ID | K780275 |
| 510k Number | K780275 |
| Device Name: | INFLUENZA HA ANTIGEN A/USSR |
| Classification | Antigens, Ha (including Ha Control), Influenza Virus A, B, C |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GNT |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-17 |
| Decision Date | 1978-02-28 |