MODIFICATION TO AVIE A1C TEST SYSTEM— 510(k) K091400

Name: FDA 510(k) clearance K091400
Creator: U.S. Food and Drug Administration
Published: 2009-06-11

Substantially Equivalent

Mec Dynamics Corp

FDA 510(k) clearance K091400 for MODIFICATION TO AVIE A1C TEST SYSTEM, Substantially Equivalent on 2009-06-11. 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: 2009-05-12
Decision date: 2009-06-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Clara, 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.