Clearance Summary
SULTAN SPOROX TEST VIAL, MODEL 75195 received FDA 510(k) clearance under submission number K020612, sponsored by Sultan Chemists, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2002-05-07.
- Submission: K020612
- Applicant / Sponsor: Sultan Chemists, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2002-05-07
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.