Source document or public record
FDA 510(k) K200595 — CellaVision DC-1, CellaVision DC-1 PPA
FDA 510(k) index record K200595. Device: CellaVision DC-1, CellaVision DC-1 PPA. Applicant as listed: CellaVision AB. Decision date: 2020-10-16.
Source
"device_name": "CellaVision DC-1, CellaVision DC-1 PPA"
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 K200595.
Device name: CellaVision DC-1, CellaVision DC-1 PPA. Applicant as listed: CellaVision AB.
Decision date: 2020-10-16. Decision wording: Substantially Equivalent.
Product code: JOY. Regulation: 21 CFR 864.5260. 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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.