The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Digoxin Assay, Lan.0700/2700, 240/144 Kit.
Device ID | K880823 |
510k Number | K880823 |
Device Name: | AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT |
Classification | Enzyme Immunoassay, Digoxin |
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 | KXT |
CFR Regulation Number | 862.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-01 |
Decision Date | 1988-05-31 |