Source document or public record
FDA 510(k) K230035 — BioSci Disposable Virus Sampling Tubes
FDA 510(k) index record K230035. Device: BioSci Disposable Virus Sampling Tubes. Applicant as listed: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Decision date: 2023-04-05.
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"device_name": "BioSci Disposable Virus Sampling Tubes"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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2026-10-20
2026-10-20
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FDA 510(k) public index record K230035.
Device name: BioSci Disposable Virus Sampling Tubes. Applicant as listed: Shenzhen Dakewe Bio-Engineering Co., Ltd..
Decision date: 2023-04-05. 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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