FDA Review Panel · MG

FDA 510(k) Medical Genetics Devices

About Medical Genetics Devices

FDA 510(k) medical genetics devices include instruments and systems used for genetic analysis and molecular diagnostics. The FDA review panel code is MG.

This is a small but rapidly growing category as many genetic tests follow the PMA or De Novo pathway instead of 510(k). Current submissions include:

  • DNA sequencing systems - next-generation sequencing (NGS) platforms
  • PCR-based diagnostic systems - real-time PCR for genetic variant detection
  • Chromosomal analysis instruments - karyotyping and FISH systems

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FDA 510(k) Cleared Medical Genetics Devices

This page lists all 0 medical devices in the Medical Genetics specialty that have been submitted to the FDA through the 510(k) premarket notification process. Genetic testing systems, molecular diagnostics and genomic analysis tools.

  • devices cleared as substantially equivalent to a predicate device.
  • Average time to FDA decision: data not available.
  • Records available from to the present.
  • Filter by product code using the sidebar to narrow results by device type.
0 Medical Genetics devices
No devices found.

How to use this database

This page lists 0 medical devices in the Medical Genetics specialty submitted to the FDA through the 510(k) premarket notification process. Of these, were cleared as substantially equivalent to a predicate device. Average FDA review time: N/A. Records from 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 medical genetics
  • 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.

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