Cleared Traditional

MicroScan Prompt Inoculation System-D

K221493 · Beckman Coulter, Inc. · Microbiology
Apr 2023
Decision
317d
Days
Class 2
Risk

About This 510(k) Submission

K221493 is an FDA 510(k) clearance for the MicroScan Prompt Inoculation System-D, a Reagent/device, Inoculum Calibration (Class II — Special Controls, product code LIE), submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 5, 2023, 317 days after receiving the submission on May 23, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K221493 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2022
Decision Date April 05, 2023
Days to Decision 317 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIE — Reagent/device, Inoculum Calibration
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640