PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY

Glucose Dehydrogenase, Glucose

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Precision Point Of Care Blood Glucose Test Strip With True Measure Technology.

Pre-market Notification Details

Device IDK021960
510k NumberK021960
Device Name:PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
ClassificationGlucose Dehydrogenase, Glucose
Applicant ABBOTT LABORATORIES 4-A CROSBY DR. Bedford,  MA  01730 -1402
ContactJanet S Connolly
CorrespondentJanet S Connolly
ABBOTT LABORATORIES 4-A CROSBY DR. Bedford,  MA  01730 -1402
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-14
Decision Date2002-08-16
Summary:summary

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