The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tsh-60 Assay Product Code: Lan. 0008/2008.
| Device ID | K904666 |
| 510k Number | K904666 |
| Device Name: | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | B Patterson |
| Correspondent | B Patterson AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-15 |
| Decision Date | 1990-11-02 |