The following data is part of a premarket notification filed by Medcom Diagnostics, Inc. with the FDA for Thyrodot-4 Antisera Lyopholized.
| Device ID | K772064 |
| 510k Number | K772064 |
| Device Name: | THYRODOT-4 ANTISERA LYOPHOLIZED |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | MEDCOM DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-02 |
| Decision Date | 1977-11-14 |