Source document or public record
FDA 510(k) K191184 — ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
FDA 510(k) index record K191184. Device: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test. Applicant as listed: Ssi Diagnostica A/S. Decision date: 2020-03-05.
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"device_name": "ImmuView S pneumoniae and L pneumophila Urinary Antigen Test"
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 K191184.
Device name: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test. Applicant as listed: Ssi Diagnostica A/S.
Decision date: 2020-03-05. Decision wording: Substantially Equivalent.
Product code: MJH. Regulation: 21 CFR 866.3300. 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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