Documento fuente o registro público
FDA 510(k) K201570 — PF4 Enhanced assay
FDA 510(k) index record K201570. Device: PF4 Enhanced assay. Applicant as listed: Immucor Gti Diagnostics, Inc.. Decision date: 2020-09-11.
Fuente
"device_name": "PF4 Enhanced assay"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K201570.
Device name: PF4 Enhanced assay. Applicant as listed: Immucor Gti Diagnostics, Inc..
Decision date: 2020-09-11. Decision wording: Substantially Equivalent.
Product code: LCO. Regulation: 21 CFR 864.7695. 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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