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 |