Source document or public record
FDA 510(k) K211342 — Sofia 2 Campylobacter FIA
FDA 510(k) index record K211342. Device: Sofia 2 Campylobacter FIA. Applicant as listed: Quidel Corporation. Decision date: 2021-11-23.
Source
"device_name": "Sofia 2 Campylobacter FIA"
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 K211342.
Device name: Sofia 2 Campylobacter FIA. Applicant as listed: Quidel Corporation.
Decision date: 2021-11-23. Decision wording: Substantially Equivalent.
Product code: LQP. 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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