The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Free Thyroid Control Sera Lan.4002.
Device ID | K883124 |
510k Number | K883124 |
Device Name: | AMERLITE FREE THYROID CONTROL SERA LAN.4002 |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Frank Lyman |
Correspondent | Frank Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | JJY |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-26 |
Decision Date | 1988-09-30 |