The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tsh-60 Assay Product Code: Lan. 0008/2008.
Device ID | K904666 |
510k Number | K904666 |
Device Name: | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | B Patterson |
Correspondent | B Patterson AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-15 |
Decision Date | 1990-11-02 |