Documento fuente o registro público
FDA 510(k) K193041 — Hemochron Signature Elite
FDA 510(k) index record K193041. Device: Hemochron Signature Elite. Applicant as listed: Accriva Diagnostics, Inc.. Decision date: 2019-11-22.
Fuente
"device_name": "Hemochron Signature Elite"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K193041.
Device name: Hemochron Signature Elite. Applicant as listed: Accriva Diagnostics, Inc..
Decision date: 2019-11-22. Decision wording: Substantially Equivalent.
Product code: JPA. Regulation: 21 CFR 864.5425. 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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