Clearance Summary
Greiner Holdex received FDA 510(k) clearance under submission number K160532, sponsored by Greiner Bio-One Na, 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 2016-11-03.
- Submission: K160532
- Applicant / Sponsor: Greiner Bio-One Na, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2016-11-03
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.