The following data is part of a premarket notification filed by Environmental Chemical Specialties with the FDA for Tdm Anti-convulsant Control Levels I-ii.
| Device ID | K811811 |
| 510k Number | K811811 |
| Device Name: | TDM ANTI-CONVULSANT CONTROL LEVELS I-II |
| Classification | Drug Mixture Control Materials |
| Applicant | ENVIRONMENTAL CHEMICAL SPECIALTIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-25 |
| Decision Date | 1981-07-10 |