The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ferritin Assay, Lan.0800/1800/2800.
| Device ID | K874203 |
| 510k Number | K874203 |
| Device Name: | AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Donald E Baker |
| Correspondent | Donald E Baker AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-15 |
| Decision Date | 1988-01-27 |