Source document or public record
FDA 510(k) K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
FDA 510(k) index record K243455. Device: cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-07-31.
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"device_name": "cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems"
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 K243455.
Device name: cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems. Applicant as listed: Roche Molecular Systems, Inc..
Decision date: 2025-07-31. Decision wording: Substantially Equivalent.
Product code: QOF. Regulation: 21 CFR 866.3981. 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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