The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ft3 Assay, Lan.0007/2007 240/144 Test Kit.
| Device ID | K885195 |
| 510k Number | K885195 |
| Device Name: | AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| 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 | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-16 |
| Decision Date | 1989-02-08 |