Clearance Summary
SAFE-STRIPS received FDA 510(k) clearance under submission number K880548, sponsored by Medstar, 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 1988-09-29.
- Submission: K880548
- Applicant / Sponsor: Medstar, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1988-09-29
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.