Source document or public record
FDA 510(k) K233946 — IMMULITE® 2000 BR-MA
FDA 510(k) index record K233946. Device: IMMULITE® 2000 BR-MA. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2024-03-13.
Source
"device_name": "IMMULITE® 2000 BR-MA"
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 K233946.
Device name: IMMULITE® 2000 BR-MA. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd..
Decision date: 2024-03-13. Decision wording: Substantially Equivalent.
Product code: MOI. Regulation: 21 CFR 866.6010. 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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