The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerliite Ft4 Assay Lan.0006/2006 240/144 Test Kit.
| Device ID | K883123 |
| 510k Number | K883123 |
| Device Name: | AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank Lyman |
| Correspondent | Frank Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-12-22 |