The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Thyro-zyme-t4 Assay Kit.
| Device ID | K780401 |
| 510k Number | K780401 |
| Device Name: | THYRO-ZYME-T4 ASSAY KIT |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | COULTER ELECTRONICS, 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 | 1978-03-13 |
| Decision Date | 1978-04-24 |