Source document or public record
FDA 510(k) K261380 — Concentriq AP-Dx
FDA 510(k) index record K261380. Device: Concentriq AP-Dx. Applicant as listed: Proscia, Inc.. Decision date: 2026-08-05.
Source
"device_name": "Concentriq AP-Dx"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K261380.
Device name: Concentriq AP-Dx. Applicant as listed: Proscia, Inc..
Decision date: 2026-08-05. Decision wording: Substantially Equivalent.
Product code: QKQ. Regulation: 21 CFR 864.3700. Medical specialty: Pathology.
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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.