Clearance Summary
PROADENO+ ASSAY received FDA 510(k) clearance under submission number K132159, sponsored by Gen-Probe Prodesse, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2013-08-14.
- Submission: K132159
- Applicant / Sponsor: Gen-Probe Prodesse, Inc.
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3980
- Decision date: 2013-08-14
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.