SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277

System, Test, Blood Glucose, Over The Counter

Biotest Medical Corp.

The following data is part of a premarket notification filed by Biotest Medical Corp. with the FDA for Smartest Persona Blood Glucose Test Sytem Model: 6277.

Pre-market Notification Details

Device IDK100701
510k NumberK100701
Device Name:SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Biotest Medical Corp. NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZU Taichung,  TW 427
ContactMaggie Chu
CorrespondentMaggie Chu
Biotest Medical Corp. NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZU Taichung,  TW 427
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-12
Decision Date2010-04-08
Summary:summary

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