BCS GLUCOSE COLORIMETRIC TEST

Glucose Oxidase, Glucose

BIOCLINICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Bioclinical Systems, Inc. with the FDA for Bcs Glucose Colorimetric Test.

Pre-market Notification Details

Device IDK850257
510k NumberK850257
Device Name:BCS GLUCOSE COLORIMETRIC TEST
ClassificationGlucose Oxidase, Glucose
Applicant BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis,  MO  63139
ContactBruce F Watkins
CorrespondentBruce F Watkins
BIOCLINICAL SYSTEMS, INC. 5977 SOUTHWEST AVE. St.louis,  MO  63139
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-22
Decision Date1985-03-05

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