The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-mab Ft4 Kit.
Device ID | K894091 |
510k Number | K894091 |
Device Name: | AMERLEX-MAB FT4 KIT |
Classification | Radioimmunoassay, Free Thyroxine |
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 | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-09 |
Decision Date | 1989-08-03 |