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510(k) K093548

AVIE A1C TEST SYSTEM by Mec Dynamics Corp — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2011
Date Received
November 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

Other clearances by Mec Dynamics Corp

  • K121752 — AVIE TOTAL HB TEST SYSTEM (January 7, 2013)
  • K091400 — MODIFICATION TO AVIE A1C TEST SYSTEM (June 11, 2009)
  • K081269 — AVIE A1C TEST SYSTEM (March 20, 2009)

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