Clearance Summary
GenetiSure Dx Postnatal Assay received FDA 510(k) clearance under submission number K163367, sponsored by Agilent Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2017-08-11.
- Submission: K163367
- Applicant / Sponsor: Agilent Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5920
- Decision date: 2017-08-11
Classification & Regulation
This clearance is catalogued under FDA product code PFX and 21 CFR 866.5920, within the Immunology review panel as a Class II device.