The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Free T-4 Radioimmunoassay Kit.
| Device ID | K842482 |
| 510k Number | K842482 |
| Device Name: | AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | AMERSHAM CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-25 |
| Decision Date | 1984-08-10 |