Source document or public record
FDA 510(k) K232057 — BÜHLMANN fCAL® turbo and CALEX® Cap
FDA 510(k) index record K232057. Device: BÜHLMANN fCAL® turbo and CALEX® Cap. Applicant as listed: Bühlmann Laboratories AG. Decision date: 2024-02-06.
Source
"device_name": "BÜHLMANN fCAL® turbo and CALEX® Cap"
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 K232057.
Device name: BÜHLMANN fCAL® turbo and CALEX® Cap. Applicant as listed: Bühlmann Laboratories AG.
Decision date: 2024-02-06. Decision wording: Substantially Equivalent.
Product code: NXO. Regulation: 21 CFR 866.5180. Medical specialty: Immunology.
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.