The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Plex-id Flu Assay.
| Device ID | K121003 |
| 510k Number | K121003 |
| Device Name: | ABBOTT PLEX-ID FLU ASSAY |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | ABBOTT LABORATORIES 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Contact | Darren Clarke |
| Correspondent | Darren Clarke ABBOTT LABORATORIES 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Product Code | OCC |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OQW |
| Subsequent Product Code | OTA |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-12-21 |
| Summary: | summary |