The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Digoxin Assay, Lan.0700/2700, 240/144 Kit.
| Device ID | K880823 |
| 510k Number | K880823 |
| Device Name: | AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank J Lyman |
| Correspondent | Frank J Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-05-31 |