Clearance Summary
SPSMEDICAL SPORVIEW PA CULTURE SET received FDA 510(k) clearance under submission number K043135, sponsored by Spsmedical Supply Corp.. 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 2005-01-13.
- Submission: K043135
- Applicant / Sponsor: Spsmedical Supply Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2005-01-13
Classification & Regulation
This clearance is catalogued under FDA product code MRB and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.