Source document or public record
FDA 510(k) K200811 — cobas u 701 microscopy analyzer
FDA 510(k) index record K200811. Device: cobas u 701 microscopy analyzer. Applicant as listed: Roche Diagnostics. Decision date: 2020-11-06.
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"device_name": "cobas u 701 microscopy analyzer"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K200811.
Device name: cobas u 701 microscopy analyzer. Applicant as listed: Roche Diagnostics.
Decision date: 2020-11-06. Decision wording: Substantially Equivalent.
Product code: LKM. Regulation: 21 CFR 864.5200. Medical specialty: Hematology.
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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