Documento fuente o registro público
FDA 510(k) K252323 — cobas pulse blood glucose monitoring system
FDA 510(k) index record K252323. Device: cobas pulse blood glucose monitoring system. Applicant as listed: Roche Diagnostics. Decision date: 2026-06-12.
Fuente
"device_name": "cobas pulse blood glucose monitoring system"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-22
professional use
FDA 510(k) public index record K252323.
Device name: cobas pulse blood glucose monitoring system. Applicant as listed: Roche Diagnostics.
Decision date: 2026-06-12. Decision wording: Substantially Equivalent.
Product code: PZI. Regulation: 21 CFR 862.1345. Medical specialty: Clinical Chemistry.
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.
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