Source document or public record
FDA 510(k) K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
FDA 510(k) index record K213510. Device: IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2023-09-08.
Source
"device_name": "IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-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 K213510.
Device name: IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd..
Decision date: 2023-09-08. Decision wording: Substantially Equivalent.
Product code: LTK. 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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