The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite T3u Assay Lan.0004/1004/2004, 240/480/144.
| Device ID | K874362 |
| 510k Number | K874362 |
| Device Name: | AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 |
| Classification | Radioassay, Triiodothyronine Uptake |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Jan L Zorn |
| Correspondent | Jan L Zorn AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-23 |
| Decision Date | 1988-02-18 |