Clearance Summary
48 HOUR BIOLOGICAL INDICATORS SPORSTRIP received FDA 510(k) clearance under submission number K841709, sponsored by Skyland Scientific Services, 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 1984-10-02.
- Submission: K841709
- Applicant / Sponsor: Skyland Scientific Services, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1984-10-02
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.