CHARISE CHARLES REAGENT STRIPS

Method, Enzymatic, Glucose (urinary, Non-quantitative)

LEE IMPORT DOMESTIC CONSULTING

The following data is part of a premarket notification filed by Lee Import Domestic Consulting with the FDA for Charise Charles Reagent Strips.

Pre-market Notification Details

Device IDK895282
510k NumberK895282
Device Name:CHARISE CHARLES REAGENT STRIPS
ClassificationMethod, Enzymatic, Glucose (urinary, Non-quantitative)
Applicant LEE IMPORT DOMESTIC CONSULTING 3049 GREENMOUNT RD. Orlando,  FL  32806
ContactLavar R Lee
CorrespondentLavar R Lee
LEE IMPORT DOMESTIC CONSULTING 3049 GREENMOUNT RD. Orlando,  FL  32806
Product CodeJIL  
CFR Regulation Number862.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-24
Decision Date1990-01-10

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