Cleared Traditional

Cultura Collection and Transport System

K201674 · Merit Medical Systems, Inc. · Microbiology
Mar 2021
Decision
257d
Days
Class 1
Risk

About This 510(k) Submission

K201674 is an FDA 510(k) clearance for the Cultura Collection and Transport System, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 3, 2021, 257 days after receiving the submission on June 19, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K201674 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2020
Decision Date March 03, 2021
Days to Decision 257 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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