GENERIC BLOOD GLUCOSE TEST STRIP

Glucose Oxidase, Glucose

INBIOS INTL., INC.

The following data is part of a premarket notification filed by Inbios Intl., Inc. with the FDA for Generic Blood Glucose Test Strip.

Pre-market Notification Details

Device IDK001092
510k NumberK001092
Device Name:GENERIC BLOOD GLUCOSE TEST STRIP
ClassificationGlucose Oxidase, Glucose
Applicant INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle,  WA  98104
ContactEstela I Raychaudhuri
CorrespondentEstela I Raychaudhuri
INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle,  WA  98104
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-04
Decision Date2000-07-26

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