The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Ames Tda Tm Phenytoin Test.
| Device ID | K811025 |
| 510k Number | K811025 |
| Device Name: | AMES TDA TM PHENYTOIN TEST |
| Classification | Fluorescent Immunoassay, Diphenylhydantoin |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LES |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-16 |
| Decision Date | 1981-04-29 |