AVIE A1C TEST SYSTEM— 510(k) K093548

Substantially Equivalent

Mec Dynamics Corp

FDA 510(k) clearance K093548 for AVIE A1C TEST SYSTEM, Substantially Equivalent on 2011-07-20. Applicant: Mec Dynamics Corp. Device class: 2.

Clearance details

Applicant: Mec Dynamics Corp
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2009-11-17
Decision date: 2011-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.