The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Lan.0800q/2800q.
| Device ID | K895872 |
| 510k Number | K895872 |
| Device Name: | LAN.0800Q/2800Q |
| Classification | Ferritin, Antigen, Antiserum, Control |
| 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 | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-04 |
| Decision Date | 1989-10-17 |