DIRECT BILIRUBIN REAGENT

Diazo Colorimetry, Bilirubin

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Direct Bilirubin Reagent.

Pre-market Notification Details

Device IDK841572
510k NumberK841572
Device Name:DIRECT BILIRUBIN REAGENT
ClassificationDiazo Colorimetry, Bilirubin
Applicant HI CHEM, INC. 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 Received1984-04-17
Decision Date1984-05-16

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