AVIE A1C TEST SYSTEM

Assay, Glycosylated Hemoglobin

MEC DYNAMICS CORP

The following data is part of a premarket notification filed by Mec Dynamics Corp with the FDA for Avie A1c Test System.

Pre-market Notification Details

Device IDK081269
510k NumberK081269
Device Name:AVIE A1C TEST SYSTEM
ClassificationAssay, Glycosylated Hemoglobin
Applicant MEC DYNAMICS CORP 2225 MARTIN AVE SUITE 1 Santa Clara,  CA  95050
ContactEmmanuel Mpock
CorrespondentEmmanuel Mpock
MEC DYNAMICS CORP 2225 MARTIN AVE SUITE 1 Santa Clara,  CA  95050
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-05
Decision Date2009-03-20
Summary:summary

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