BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
Becton, Dickinson and Company · K250447
FDA-authorized Predetermined Change Control Plan
- Company
- Becton, Dickinson and Company
- 510(k)/De Novo #
- K250447
- Decision date
- 2025-05-19
- Panel
- Microbiology
- Pathway
- 510(k)
- Category
- Non-AI
- PCCP type
- Other
- Monitoring commitment
- Not stated
What this PCCP covers. Permits defined post-clearance changes
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Want the monitoring teardown?
We read the PCCP for BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL), 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.
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