Source document or public record
FDA 510(k) K203270 — IMMULITE/IMMULITE® 1000 Cortisol
FDA 510(k) index record K203270. Device: IMMULITE/IMMULITE® 1000 Cortisol. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd.. Decision date: 2021-01-15.
Source
"device_name": "IMMULITE/IMMULITE® 1000 Cortisol"
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 K203270.
Device name: IMMULITE/IMMULITE® 1000 Cortisol. Applicant as listed: Siemens Healthcare Diagnostics Products, Ltd..
Decision date: 2021-01-15. Decision wording: Substantially Equivalent.
Product code: CGR. Regulation: 21 CFR 862.1205. Medical specialty: Clinical Chemistry.
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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