The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for 'tdxflx Analyzer.
| Device ID | K904226 |
| 510k Number | K904226 |
| Device Name: | 'TDXFLX ANALYZER |
| Classification | Fluorescent Immunoassay Gentamicin |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Carol Cooper |
| Correspondent | Carol Cooper ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LCQ |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-13 |
| Decision Date | 1990-10-29 |