The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-mab Ft4 Kit.
| Device ID | K894091 |
| 510k Number | K894091 |
| Device Name: | AMERLEX-MAB FT4 KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| 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 | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-09 |
| Decision Date | 1989-08-03 |