The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tt3 Assay, Lan.0003/2003 240/144 Kit.
Device ID | K881373 |
510k Number | K881373 |
Device Name: | AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT |
Classification | Radioimmunoassay, Total Triiodothyronine |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Frank J Lyman |
Correspondent | Frank J Lyman 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 | 1988-04-01 |
Decision Date | 1988-05-27 |