Disposable Sampler Viral Transport Media— 510(k) K211256

Name: FDA 510(k) clearance K211256
Creator: U.S. Food and Drug Administration
Published: 2022-05-20

Substantially Equivalent

Wuxi Nest Biotechnology Co., Ltd.

FDA 510(k) clearance K211256 for Disposable Sampler Viral Transport Media, Substantially Equivalent on 2022-05-20. Applicant: Wuxi Nest Biotechnology Co., Ltd.. Device class: 1.

Clearance details

Applicant: Wuxi Nest Biotechnology Co., Ltd.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 2021-04-26
Decision date: 2022-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code JSM

view all

K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device2025-11-26
K250205 — Babio® Virus Transport Kit (Non-inactivating)2025-09-22
K242576 — AllTest Viral Transport Medium2025-04-04
K232565 — UriSponge2024-10-11
K220908 — Ensol EnTM Specimen Collection and Transport System2024-08-29

More clearances from Wuxi Nest Biotechnology Co., Ltd.

view all

K240961 — Disposable Pen Injector Assembly2024-08-15
K240774 — Pen Injector2024-06-18
K210440 — Disposable Sampler Inactivated Transport Media, Nest ITM2021-09-20

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