AVIE TOTAL HB TEST SYSTEM— 510(k) K121752

Substantially Equivalent

Mec Dynamics Corp

FDA 510(k) clearance K121752 for AVIE TOTAL HB TEST SYSTEM, Substantially Equivalent on 2013-01-07. Applicant: Mec Dynamics Corp. Device class: 2.

Clearance details

Applicant: Mec Dynamics Corp
Product code: Code GKR
Device class: Class 2
Regulation: 21 CFR 864.5620
Advisory panel: Hematology
Date received: 2012-06-14
Decision date: 2013-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mec Dynamics Corp

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