ENDAB DIGOXIN KIT

Enzyme Immunoassay, Digoxin

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Digoxin Kit.

Pre-market Notification Details

Device IDK812054
510k NumberK812054
Device Name:ENDAB DIGOXIN KIT
ClassificationEnzyme Immunoassay, Digoxin
Applicant IMMUNOTECH CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKXT  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-07-21
Decision Date1981-08-12

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