ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY

Enzyme Immunoassay, Theophylline

IMMUNOTECH CORP.

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

Pre-market Notification Details

Device IDK802066
510k NumberK802066
Device Name:ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Theophylline
Applicant IMMUNOTECH CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLS  
CFR Regulation Number862.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-08-27
Decision Date1980-10-23

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