Cleared Traditional

MECA XPRESSFISH

K140619 · Advandx, Inc. · Microbiology

Oct 2014

Decision

213d

Days

Class 2

Risk

About This 510(k) Submission

K140619 is an FDA 510(k) clearance for the MECA XPRESSFISH, a System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies (Class II — Special Controls, product code MYI), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on October 10, 2014, 213 days after receiving the submission on March 11, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K140619 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 11, 2014
Decision Date	October 10, 2014
Days to Decision	213 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	MYI — System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640