LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067

System, Test, Blood Glucose, Over The Counter

AGAMATRIX INC

The following data is part of a premarket notification filed by Agamatrix Inc with the FDA for Liberty Blood Glucose Monitoring System, Model 8000-0067.

Pre-market Notification Details

Device IDK052762
510k NumberK052762
Device Name:LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant AGAMATRIX INC 230 ALBANY STREET Cambridge,  MA  02139
ContactConnie Hertel
CorrespondentConnie Hertel
AGAMATRIX INC 230 ALBANY STREET Cambridge,  MA  02139
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeJJX
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-30
Decision Date2006-01-23
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.