The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tdx Methotrexate.
| Device ID | K830398 |
| 510k Number | K830398 |
| Device Name: | TDX METHOTREXATE |
| Classification | Enzyme Immunoassay, Methotrexate |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LAO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-07 |
| Decision Date | 1983-03-10 |