The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tt3 Assay, Lan.0003/1003/2003.
Device ID | K873858 |
510k Number | K873858 |
Device Name: | AMERLITE TT3 ASSAY, LAN.0003/1003/2003 |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Donald E Baker |
Correspondent | Donald E Baker AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | CDP |
CFR Regulation Number | 862.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-22 |
Decision Date | 1987-11-03 |