REAGENTS 1263,1273,1284,1425,014301,053583

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 Reagents 1263,1273,1284,1425,014301,053583.

Pre-market Notification Details

Device IDK871531
510k NumberK871531
Device Name:REAGENTS 1263,1273,1284,1425,014301,053583
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 Date1987-05-18

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