The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tt4 Assay (240/480/144 Test Kits).
Device ID | K873976 |
510k Number | K873976 |
Device Name: | AMERLITE TT4 ASSAY (240/480/144 TEST KITS) |
Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
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 | KLI |
CFR Regulation Number | 862.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1987-11-05 |