Source document or public record
FDA 510(k) K223185 — BreathID® Smart System
FDA 510(k) index record K223185. Device: BreathID® Smart System. Applicant as listed: Meridian Bioscience Israel , Ltd.. Decision date: 2022-11-10.
Source
"device_name": "BreathID® Smart 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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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K223185.
Device name: BreathID® Smart System. Applicant as listed: Meridian Bioscience Israel , Ltd..
Decision date: 2022-11-10. Decision wording: Substantially Equivalent.
Product code: MSQ. Regulation: 21 CFR 866.3110. 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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