AllTest Viral Transport Medium— 510(k) K242576

Name: FDA 510(k) clearance K242576
Creator: U.S. Food and Drug Administration
Published: 2025-04-04

Substantially Equivalent

Hangzhou AllTest Biotech Co., Ltd.

FDA 510(k) clearance K242576 for AllTest Viral Transport Medium, Substantially Equivalent on 2025-04-04. Applicant: Hangzhou AllTest Biotech Co., Ltd.. Device class: 1.

Clearance details

Applicant: Hangzhou AllTest Biotech Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2024-08-29
Decision date: 2025-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

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K232565 — UriSponge2024-10-11
K220908 — Ensol EnTM Specimen Collection and Transport System2024-08-29
K240235 — OmniTrans Transport System2024-08-19

More clearances from Hangzhou AllTest Biotech Co., Ltd.

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K260342 — AllTest Strep A Rapid Test2026-04-30
K252607 — AllTest Urinary Tract Infection Test2025-10-30
K251053 — Shinetell PlusTM Digital Early Pregnancy Test2025-07-15
K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup2025-04-04
K244043 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup2025-02-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.