TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583

Diazo Colorimetry, Bilirubin

AMERICAN RESEARCH PRODUCTS CO.

The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Total Bilirubin Reagent 1372,1425,1284,1273,053583.

Pre-market Notification Details

Device IDK871530
510k NumberK871530
Device Name:TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
ClassificationDiazo Colorimetry, Bilirubin
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactJan Brownlee
CorrespondentJan Brownlee
AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-20
Decision Date1987-05-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.