The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tbg Assay, Lan.0005/1005 240/144 Test Kit.
| Device ID | K893469 |
| 510k Number | K893469 |
| Device Name: | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT |
| Classification | Radioimmunoassay, Thyroxine-binding Globulin |
| 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 | CEE |
| CFR Regulation Number | 862.1685 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-04 |
| Decision Date | 1989-08-15 |