Clearance Summary
DAKOCYTOMATION ER/PR PHARMDX KIT received FDA 510(k) clearance under submission number K042884, sponsored by Dakocytomation California, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2005-02-15.
- Submission: K042884
- Applicant / Sponsor: Dakocytomation California, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.1860
- Decision date: 2005-02-15
Classification & Regulation
This clearance is catalogued under FDA product code MXZ and 21 CFR 864.1860, within the Hematology review panel as a Class II device.