TOTAL BILIRUBIN REAGENT

Diazo Colorimetry, Bilirubin

TECH-NEAL SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Total Bilirubin Reagent.

Pre-market Notification Details

Device IDK881241
510k NumberK881241
Device Name:TOTAL BILIRUBIN REAGENT
ClassificationDiazo Colorimetry, Bilirubin
Applicant TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago,  IL  60632
ContactArun Sanghavi
CorrespondentArun Sanghavi
TECH-NEAL SCIENTIFIC, INC. 5410 S. KILPATRICK AVE. Chicago,  IL  60632
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-22
Decision Date1988-05-27

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