Cleared Traditional

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ?g/mL )

K202343 · Beckman Coulter, Inc. · Microbiology
Nov 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K202343 is an FDA 510(k) clearance for the MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 ?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 November 16, 2020, 90 days after receiving the submission on August 18, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K202343 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2020
Decision Date November 16, 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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