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# 510(k) Exemption Proposed for Flow Cytometer Instruments
- URL: https://www.fdaweb.com/510-k-exemption-proposed-for-flow-cytometer-instruments/
- Published: 2019-03-06T12:00:00.000Z
- Updated: 2026-09-15T01:10:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143538

*Federal Register* notice: FDA is seeking comments on its announced intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The agency has determined that these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other Class 2 devices classified under FDA’s automated differential cell counter regulation would continue to be subject to premarket notification requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-03-06/pdf/2019-03967.pdf?ref=fdaweb.com).