Source document or public record
FDA 510(k) K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System
FDA 510(k) index record K212427. Device: cobas Cdiff nucleic acid test for use on the cobas Liat System. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2021-10-20.
Source
"device_name": "cobas Cdiff nucleic acid test for use on the cobas Liat System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K212427.
Device name: cobas Cdiff nucleic acid test for use on the cobas Liat System. Applicant as listed: Roche Molecular Systems, Inc..
Decision date: 2021-10-20. Decision wording: Substantially Equivalent.
Product code: OZN. Regulation: 21 CFR 866.3130. 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.
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