The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Estradiol-60 Assay Lan.0081/2081.
| Device ID | K896270 |
| 510k Number | K896270 |
| Device Name: | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 |
| Classification | Radioimmunoassay, Estradiol |
| 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 | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-31 |
| Decision Date | 1989-12-12 |