The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Code Im 2050 Amerlex Free T4 Ria Kit.
| Device ID | K810231 |
| 510k Number | K810231 |
| Device Name: | CODE IM 2050 AMERLEX FREE T4 RIA KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | AMERSHAM 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 | 1981-01-27 |
| Decision Date | 1981-02-10 |