Cleared Traditional

AllTest Viral Transport Medium

K242576 · Hangzhou AllTest Biotech Co., Ltd. · Microbiology
Apr 2025
Decision
218d
Days
Class 1
Risk

About This 510(k) Submission

K242576 is an FDA 510(k) clearance for the AllTest Viral Transport Medium, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on April 4, 2025, 218 days after receiving the submission on August 29, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K242576 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2024
Decision Date April 04, 2025
Days to Decision 218 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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