The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Cortisol Enhanced Luminescence Assay Kit.
| Device ID | K880687 |
| 510k Number | K880687 |
| Device Name: | CORTISOL ENHANCED LUMINESCENCE ASSAY KIT |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Jan L Zorn |
| Correspondent | Jan L Zorn AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-03-24 |