GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK

Single (specified) Analyte Controls (assayed And Unassayed)

BIONOSTICS, INC.

The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Glucose Meter-check Solution For Roche Accu-chek.

Pre-market Notification Details

Device IDK123851
510k NumberK123851
Device Name:GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BIONOSTICS, INC. 7 JACKSON RD. Devens,  MA  01434
ContactRandy Byrd
CorrespondentRandy Byrd
BIONOSTICS, INC. 7 JACKSON RD. Devens,  MA  01434
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-12-14
Decision Date2013-02-14
Summary:summary

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