Cleared Traditional

Viral Transport Medium

K233534 · Hardy Diagnostics · Microbiology
Aug 2024
Decision
273d
Days
Class 1
Risk

About This 510(k) Submission

K233534 is an FDA 510(k) clearance for the Viral Transport Medium, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Hardy Diagnostics (Santa Monica, US). The FDA issued a Cleared decision on August 2, 2024, 273 days after receiving the submission on November 3, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K233534 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date August 02, 2024
Days to Decision 273 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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