The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Spac T3 Ria Test Kit.
| Device ID | K801125 |
| 510k Number | K801125 |
| Device Name: | SPAC T3 RIA TEST KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-12 |
| Decision Date | 1980-06-09 |