Clearance Summary
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR received FDA 510(k) clearance under submission number K031647, sponsored by Getinge USA, 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 2003-07-29.
- Submission: K031647
- Applicant / Sponsor: Getinge USA, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2003-07-29
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.