The following data is part of a premarket notification filed by Biostar, Inc. with the FDA for Ab Flu Oia.
| Device ID | K981651 |
| 510k Number | K981651 |
| Device Name: | AB FLU OIA |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301 |
| Contact | Roger C Briden |
| Correspondent | Roger C Briden BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-11 |
| Decision Date | 1998-11-25 |
| Summary: | summary |