The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex Free T-3 Ria Kit.
| Device ID | K830980 |
| 510k Number | K830980 |
| Device Name: | AMERLEX FREE T-3 RIA KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | AMERSHAM CORP. 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 | 1983-03-29 |
| Decision Date | 1983-05-25 |