ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT

Radioimmunoassay, Digitoxin (125-i)

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK802461
510k NumberK802461
Device Name:ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
ClassificationRadioimmunoassay, Digitoxin (125-i)
Applicant IMMUNOTECH CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLCW  
CFR Regulation Number862.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-08
Decision Date1980-10-31

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