The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tdx(r)/tdx(r)flx(r)mehtotrexate Ii.
| Device ID | K932615 |
| 510k Number | K932615 |
| Device Name: | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II |
| Classification | Enzyme Immunoassay, Methotrexate |
| Applicant | ABBOTT LABORATORIES ABBOTT LABS Abbott Park, IL 60064 |
| Contact | Irene Powers |
| Correspondent | Irene Powers ABBOTT LABORATORIES ABBOTT LABS Abbott Park, IL 60064 |
| 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 | 1993-06-01 |
| Decision Date | 1993-07-14 |