AVIE A1C TEST SYSTEM


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K081269
Device Name AVIE A1C TEST SYSTEM
Applicant
MEC DYNAMICS CORP
2225 martin ave
suite 1
santa clara, 
CA 
95050

Applicant Contact emmanuel mpock
Correspondent
MEC DYNAMICS CORP
2225 martin ave
suite 1
santa clara, 
CA 
95050

Correspodent Contact emmanuel mpock
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 05/05/2008
Decision Date 03/20/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No