AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)

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 Amresco Product Number 7728 (bilirubin Dpd).

Pre-market Notification Details

Device IDK900571
510k NumberK900571
Device Name:AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD)
ClassificationDiazo Colorimetry, Bilirubin
Applicant AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon,  OH  44139
ContactC. K Owens
CorrespondentC. K Owens
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 Received1990-02-07
Decision Date1990-04-16

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