Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K093548
Device Name AVIE A1C TEST SYSTEM
Applicant
Mec Dynamics Corp
90 Rose Orchard Way
San Jose,  CA  95134
Applicant Contact EMMANUEL MPOCK
Correspondent
Mec Dynamics Corp
90 Rose Orchard Way
San Jose,  CA  95134
Correspondent Contact EMMANUEL MPOCK
Regulation Number864.7470
Classification Product Code
LCP  
Date Received11/17/2009
Decision Date 07/20/2011
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
Predetermined Change
Control Plan Authorized		 No
-
-