Source document or public record
FDA 510(k) K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
FDA 510(k) index record K260047. Device: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190). Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2026-08-28.
Source
"device_name": "cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)"
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 K260047.
Device name: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190). Applicant as listed: Roche Molecular Systems, Inc..
Decision date: 2026-08-28. Decision wording: Substantially Equivalent.
Product code: PGX. Regulation: 21 CFR 866.2680. 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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