Source document or public record
FDA 510(k) K211485 — STA- NeoPTimal
FDA 510(k) index record K211485. Device: STA- NeoPTimal. Applicant as listed: Diagnostica Stago S.A.S. Decision date: 2022-12-23.
Source
"device_name": "STA- NeoPTimal"
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 K211485.
Device name: STA- NeoPTimal. Applicant as listed: Diagnostica Stago S.A.S.
Decision date: 2022-12-23. Decision wording: Substantially Equivalent.
Product code: GJS. Regulation: 21 CFR 864.7750. Medical specialty: Hematology.
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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