The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tbg Assay, Lan.0005/1005 240/144 Test Kit.
Device ID | K893469 |
510k Number | K893469 |
Device Name: | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT |
Classification | Radioimmunoassay, Thyroxine-binding Globulin |
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 | CEE |
CFR Regulation Number | 862.1685 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-04 |
Decision Date | 1989-08-15 |