VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
bioMerieux, Inc. · K260160
FDA-authorized Predetermined Change Control Plan
- Company
- bioMerieux, Inc.
- 510(k)/De Novo #
- K260160
- Decision date
- 2026-07-08
- Panel
- Microbiology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Panel expansion
- Monitoring commitment
- Unknown
What this PCCP covers. Permits panel or organism expansion
Other PCCPs from bioMerieux, Inc.
Other Microbiology PCCPs
- K261781Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60Thermo Fisher Scientific (Oxoid Ltd.)2026-07-24Non-AIUnknown
- K261853Gepotidacin GEP 10 µgLiofilchem, Inc.2026-07-23Non-AIUnknown
- K253316PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp.2026-06-26Non-AIPanel expansion
- K260842HardyDisk AST Gepotidacin 10µg (GEP10)Hardy Diagnostics2026-05-11Non-AIUnknown
- K260447ETEST Gepotidacin (GEP) (0.016-256 µg/mL)bioMérieux SA2026-04-21Non-AIPanel expansion
- K260696MTS Gepotidacin 0.016-256 µg/mLLiofilchem s.r.l.2026-04-17Non-AIPanel expansion
Want the monitoring teardown?
We read the PCCP for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.
Book a callSource: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.
This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.