Clearance Summary
PRODESSE PROADENO received FDA 510(k) clearance under submission number K102952, sponsored by Gen-Probe Prodesse, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2010-12-03.
- Submission: K102952
- Applicant / Sponsor: Gen-Probe Prodesse, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2010-12-03
Classification & Regulation
This clearance is catalogued under FDA product code OCC and 21 CFR 866.3980, within the Microbiology review panel as a Class II device.