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FDA 510(k) K192957 — VivaChek Blood Glucose and B-Ketone Monitoring System
FDA 510(k) index record K192957. Device: VivaChek Blood Glucose and B-Ketone Monitoring System. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd.. Decision date: 2020-06-05.
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"device_name": "VivaChek Blood Glucose and B-Ketone Monitoring System"
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 K192957.
Device name: VivaChek Blood Glucose and B-Ketone Monitoring System. Applicant as listed: Vivachek Biotech (Hangzhou) Co., Ltd..
Decision date: 2020-06-05. Decision wording: Substantially Equivalent.
Product code: JIN. Regulation: 21 CFR 862.1435. Medical specialty: Clinical Chemistry.
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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