Clearance Summary
Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer received FDA 510(k) clearance under submission number K191030, sponsored by Life Technologies Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-02-21.
- Submission: K191030
- Applicant / Sponsor: Life Technologies Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.2570
- Decision date: 2020-02-21
Classification & Regulation
This clearance is catalogued under FDA product code PCA and 21 CFR 862.2570, within the Clinical Chemistry review panel as a Class II device.