FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

Single (specified) Analyte Controls (assayed And Unassayed)

FUJIREBIO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fdi Glucose Control Solution For Use With Accu-chek Aviva.

Pre-market Notification Details

Device IDK123612
510k NumberK123612
Device Name:FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant FUJIREBIO DIAGNOSTICS, INC. 940 CROSSROADS BLVD. Seguin,  TX  78155
ContactKent Pruett
CorrespondentKent Pruett
FUJIREBIO DIAGNOSTICS, INC. 940 CROSSROADS BLVD. Seguin,  TX  78155
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-23
Decision Date2013-01-17
Summary:summary

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