Clearance Summary
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR received FDA 510(k) clearance under submission number K993104, sponsored by Nova Biomedical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1999-12-02.
- Submission: K993104
- Applicant / Sponsor: Nova Biomedical Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7500
- Decision date: 1999-12-02
Classification & Regulation
This clearance is catalogued under FDA product code GLY and 21 CFR 864.7500, within the Hematology review panel as a Class II device.