The following data is part of a premarket notification filed by Fisher Diagnostics with the FDA for Therachem Tdc Therapeutic Drug Control.
| Device ID | K840921 |
| 510k Number | K840921 |
| Device Name: | THERACHEM TDC THERAPEUTIC DRUG CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | FISHER DIAGNOSTICS 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 | 1984-03-02 |
| Decision Date | 1984-04-05 |