Panel expansion PCCPs
4 of the 155 FDA-authorized PCCPs are Panel expansion plans. Here is the full list, newest first.
- K253316PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp.2026-06-26Non-AIPanel expansion
- 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
- K253573ASTar BC G- KitQ-Linea AB2026-04-15AI hardwarePanel expansion
Other PCCP types
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We read the Panel expansion PCCPs in this list, 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.