ABT GLUCOSE CONTROL SOLUTION

Single (specified) Analyte Controls (assayed And Unassayed)

AMERICAN BIOLOGICAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by American Biological Technologies, Inc. with the FDA for Abt Glucose Control Solution.

Pre-market Notification Details

Device IDK083549
510k NumberK083549
Device Name:ABT GLUCOSE CONTROL SOLUTION
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant AMERICAN BIOLOGICAL TECHNOLOGIES, INC. 940 CROSSROADS BLVD. Seguin,  TX  78155
ContactJohn Gormley
CorrespondentJohn Gormley
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. 940 CROSSROADS BLVD. Seguin,  TX  78155
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-01
Decision Date2008-12-22
Summary:summary

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