Source document or public record
FDA 510(k) K201674 — Cultura Collection and Transport System
FDA 510(k) index record K201674. Device: Cultura Collection and Transport System. Applicant as listed: Merit Medical Systems, Inc.. Decision date: 2021-03-03.
Source
"device_name": "Cultura Collection and Transport System"
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 K201674.
Device name: Cultura Collection and Transport System. Applicant as listed: Merit Medical Systems, Inc..
Decision date: 2021-03-03. Decision wording: Substantially Equivalent.
Product code: JSM. Regulation: 21 CFR 866.2390. Medical specialty: Microbiology.
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.