The following data is part of a premarket notification filed by Damon Corp. with the FDA for Ria Test Kit Sys. Damon Kiquisol Free.
| Device ID | K781012 |
| 510k Number | K781012 |
| Device Name: | RIA TEST KIT SYS. DAMON KIQUISOL FREE |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | DAMON CORP. 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 | 1978-06-16 |
| Decision Date | 1978-07-27 |