The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex Digoxin Ria Kit.
| Device ID | K801413 |
| 510k Number | K801413 |
| Device Name: | AMERLEX DIGOXIN RIA KIT |
| Classification | Radioimmunoassay, Digoxin (125-i) |
| Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCS |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-16 |
| Decision Date | 1980-07-08 |