The following data is part of a premarket notification filed by Thermo Biostar, Inc. with the FDA for Rsv Oia.
| Device ID | K021172 |
| 510k Number | K021172 |
| Device Name: | RSV OIA |
| Classification | Antisera, Cf, Poliovirus 1-3 |
| Applicant | THERMO BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301 |
| Contact | Kohn G Adams |
| Correspondent | Kohn G Adams THERMO BIOSTAR, INC. 6655 LOOKOUT RD. Boulder, CO 80301 |
| Product Code | GOG |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-12 |
| Decision Date | 2002-09-13 |
| Summary: | summary |