DIRECT BILIRUBIN REAGENT

Diazo Colorimetry, Bilirubin

AMERICAN DADE

The following data is part of a premarket notification filed by American Dade with the FDA for Direct Bilirubin Reagent.

Pre-market Notification Details

Device IDK840777
510k NumberK840777
Device Name:DIRECT BILIRUBIN REAGENT
ClassificationDiazo Colorimetry, Bilirubin
Applicant AMERICAN DADE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-08
Decision Date1984-04-05

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