Avie A1C Test System

FDA 510(k) K081269 · Mec Dynamics Corp

Substantially Equivalent

510(k) numberK081269

Submission

Device name
Avie A1C Test System
Applicant
Mec Dynamics Corp
Santa Clara, CA, US
Received
May 5, 2008
Decision date
March 20, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LCP – Assay, Glycosylated Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7470
Specialty
Hematology

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More from Alfa Wassermann Diagnostic Technologies, LLC

510(k)DeviceDecision
K121752Avie Total HB Test SystemGKR · Traditional 01/07/2013SE
K093548Avie A1C Test SystemLCP · Traditional 07/20/2011SE
K091400Modification to Avie A1C Test SystemLCP · Special 06/11/2009SE

Questions and answers

When was Avie A1C Test System cleared by the FDA?

Avie A1C Test System (K081269) received a 510(k) decision of Substantially Equivalent on March 20, 2009, 319 days after the submission was received.

What is the product code of K081269?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.