The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Pediatric Thyroxine Test Sys. T4.
| Device ID | K771609 |
| 510k Number | K771609 |
| Device Name: | PEDIATRIC THYROXINE TEST SYS. T4 |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1977-08-22 |
| Decision Date | 1977-12-20 |