The following data is part of a premarket notification filed by Thermo Biostar, Inc. with the FDA for Flu Oia A/b Test Kit.
| Device ID | K023556 |
| 510k Number | K023556 |
| Device Name: | FLU OIA A/B TEST KIT |
| Classification | Devices Detecting Influenza A, B, And C Virus Antigens |
| Applicant | THERMO BIOSTAR, INC. 331 SOUTH 104 ST. Louisville, CO 80027 |
| Contact | John G Adams |
| Correspondent | John G Adams THERMO BIOSTAR, INC. 331 SOUTH 104 ST. Louisville, CO 80027 |
| Product Code | PSZ |
| CFR Regulation Number | 866.3328 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2003-03-27 |
| Summary: | summary |