The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Tsh Assay, Lan.0001/2001 240 & 144 Kit.
Device ID | K882907 |
510k Number | K882907 |
Device Name: | AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
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 | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-12 |
Decision Date | 1988-09-22 |