Source document or public record
FDA 510(k) K230901 — Premier HpSA Flex (619096)
FDA 510(k) index record K230901. Device: Premier HpSA Flex (619096). Applicant as listed: Meridian Bioscience, Inc.. Decision date: 2023-07-03.
Source
"device_name": "Premier HpSA Flex (619096)"
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 K230901.
Device name: Premier HpSA Flex (619096). Applicant as listed: Meridian Bioscience, Inc..
Decision date: 2023-07-03. Decision wording: Substantially Equivalent.
Product code: LYR. Regulation: 21 CFR 866.3110. 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.