Cleared Traditional

MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)

K193358 · Beckman Coulter, Inc. · Microbiology
Mar 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K193358 is an FDA 510(k) clearance for the MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL), a Panels, Test, Susceptibility, Antimicrobial (Class II — Special Controls, product code LTT), submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on March 3, 2020, 90 days after receiving the submission on December 4, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K193358 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2019
Decision Date March 03, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LTT — Panels, Test, Susceptibility, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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