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510(k) K091400

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2009
Date Received
May 12, 2009
Clearance Type
Special
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)
  • K081269 — AVIE A1C TEST SYSTEM (March 20, 2009)

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