The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Phase Ii Free T4 Kit.
| Device ID | K840901 |
| 510k Number | K840901 |
| Device Name: | PHASE II FREE T4 KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | MEDICAL & SCIENTIFIC DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-28 |
| Decision Date | 1984-04-25 |