Documento fuente o registro público
FDA 510(k) K211707 — BioTeke Sterile Disposable Virus Sampling Kit
FDA 510(k) index record K211707. Device: BioTeke Sterile Disposable Virus Sampling Kit. Applicant as listed: Bioteke Corporation (Wuxi) Co., Ltd.. Decision date: 2022-05-04.
Fuente
"device_name": "BioTeke Sterile Disposable Virus Sampling Kit"
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Automated FDA record verification
2026-10-20
2026-10-31
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FDA 510(k) public index record K211707.
Device name: BioTeke Sterile Disposable Virus Sampling Kit. Applicant as listed: Bioteke Corporation (Wuxi) Co., Ltd..
Decision date: 2022-05-04. Decision wording: Substantially Equivalent.
Product code: JSM. Regulation: 21 CFR 866.2390. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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