MECA XPRESSFISH— 510(k) K140619

Substantially Equivalent

Advandx, Inc.

FDA 510(k) clearance K140619 for MECA XPRESSFISH, Substantially Equivalent on 2014-10-10. Applicant: Advandx, Inc.. Device class: 2.

Clearance details

Applicant: Advandx, Inc.
Product code: Code MYI
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2014-03-11
Decision date: 2014-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, 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.