The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Tdx/tdxflx And Tdxflx Theophylline.
| Device ID | K922991 |
| 510k Number | K922991 |
| Device Name: | ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE |
| Classification | Fluorescence Polarization Immunoassay, Theophylline |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Carol M Cooper |
| Correspondent | Carol M Cooper ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LGS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1992-08-27 |