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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name assay, glycosylated hemoglobin
510(k) Number K091400
Device Name MODIFICATION TO AVIE A1C TEST SYSTEM
Applicant
MEC DYNAMICS CORP
2225 MARTIN AVE
SUITE I
SANTA CLARA,  CA  95050
Applicant Contact EMMANUEL MPOCK
Correspondent
MEC DYNAMICS CORP
2225 MARTIN AVE
SUITE I
SANTA CLARA,  CA  95050
Correspondent Contact EMMANUEL MPOCK
Regulation Number864.7470
Classification Product Code
LCP  
Date Received05/12/2009
Decision Date 06/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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