Beckman Coulter, Inc. — FDA PCCPs

Beckman Coulter, Inc. holds 3 FDA-authorized PCCPs in this tracker. Here is the full list, newest first.

K243804MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)Beckman Coulter, Inc.2025-08-20Non-AIUnknown
K250036MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)Beckman Coulter, Inc.2025-08-15Non-AIUnknown
K250084MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)Beckman Coulter, Inc.2025-07-18Non-AIUnknown

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We read the Beckman Coulter, Inc. 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.

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Source: 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.