FDA 510(k) Microbiology Devices
About Microbiology Devices
FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.
Key device types:
- Blood culture systems - automated incubation and detection platforms
- Microbial identification - MALDI-TOF, biochemical and molecular ID systems
- Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
- Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
- Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens
FDA 510(k) Cleared Microbiology Devices
This page lists all 221 medical devices in the Microbiology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Culture systems, microbial identification and infectious disease test kits.
- 214 devices cleared as substantially equivalent to a predicate device.
- Average time to FDA decision: 173 days.
- Records available from 2021 to the present.
- Filter by product code using the sidebar to narrow results by device type.
How to use this database
This page lists 221 medical devices in the Microbiology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 214 were cleared as substantially equivalent to a predicate device. Average FDA review time: 173 days. Records from 2021 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to microbiology
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific microbiology device? Search by device name, K-number or manufacturer.
Search all Microbiology 510(k) devices