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 |