The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m T4 Ria Kit For Serum And Plasma.
| Device ID | K860251 |
| 510k Number | K860251 |
| Device Name: | AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Dennis W Henkelman |
| Correspondent | Dennis W Henkelman 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 | 1986-01-24 |
| Decision Date | 1986-02-11 |