AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT

Enzyme Immunoassay, Digoxin

AMERSHAM CORP.

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.

Pre-market Notification Details

Device IDK880823
510k NumberK880823
Device Name:AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
ClassificationEnzyme Immunoassay, Digoxin
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactFrank J Lyman
CorrespondentFrank J Lyman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeKXT  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-01
Decision Date1988-05-31

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