Cleared Special

MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ?g/mL)

K201423 · Beckman Coulter, Inc. · Microbiology
Jun 2020
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K201423 is an FDA 510(k) clearance for the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ?g/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 June 29, 2020, 31 days after receiving the submission on May 29, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K201423 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2020
Decision Date June 29, 2020
Days to Decision 31 days
Submission Type Special
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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