The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tt4 Assay (240/480/144 Test Kits).
| Device ID | K873976 |
| 510k Number | K873976 |
| Device Name: | AMERLITE TT4 ASSAY (240/480/144 TEST KITS) |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| 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 | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-29 |
| Decision Date | 1987-11-05 |