Source document or public record
FDA 510(k) K212379 — N Latex FLC kappa, N Latex FLC lambda
FDA 510(k) index record K212379. Device: N Latex FLC kappa, N Latex FLC lambda. Applicant as listed: Siemens Healthcare Diagnostics Products GmbH. Decision date: 2022-03-02.
Source
"device_name": "N Latex FLC kappa, N Latex FLC lambda"
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 K212379.
Device name: N Latex FLC kappa, N Latex FLC lambda. Applicant as listed: Siemens Healthcare Diagnostics Products GmbH.
Decision date: 2022-03-02. Decision wording: Substantially Equivalent.
Product code: DFH. Regulation: 21 CFR 866.5550. Medical specialty: Immunology.
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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