Clearance Summary
Stat Profile Prime Plus Analyzer System received FDA 510(k) clearance under submission number K180186, sponsored by Nova Biomedical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2018-08-23.
- Submission: K180186
- Applicant / Sponsor: Nova Biomedical Corporation
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7500
- Decision date: 2018-08-23
Classification & Regulation
This clearance is catalogued under FDA product code GGZ and 21 CFR 864.7500, within the Hematology review panel as a Class II device.