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510(k) K081269

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2009
Date Received
May 5, 2008
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)
  • K093548 — AVIE A1C TEST SYSTEM (July 20, 2011)
  • K091400 — MODIFICATION TO AVIE A1C TEST SYSTEM (June 11, 2009)

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