MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3

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 Multi-meter Glucose Calibration Verification Material, Model Rna Gl3.

Pre-market Notification Details

Device IDK012430
510k NumberK012430
Device Name:MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant BIONOSTICS, INC. 2 CRAIG RD. Acton,  MA  01720
ContactKathy Storro
CorrespondentKathy Storro
BIONOSTICS, INC. 2 CRAIG RD. Acton,  MA  01720
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-31
Decision Date2001-08-27
Summary:summary

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