Clearance Summary
PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 received FDA 510(k) clearance under submission number K101853, sponsored by Diadexus, 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 2011-01-03.
- Submission: K101853
- Applicant / Sponsor: Diadexus, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5600
- Decision date: 2011-01-03
Classification & Regulation
This clearance is catalogued under FDA product code NOE and 21 CFR 866.5600, within the Immunology review panel as a Class II device.