Clearance Summary
PROGASTRO SSCS ASSAY received FDA 510(k) clearance under submission number K123274, 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 2013-01-16.
- Submission: K123274
- Applicant / Sponsor: Gen-Probe Prodesse, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3990
- Decision date: 2013-01-16
Classification & Regulation
This clearance is catalogued under FDA product code PCH and 21 CFR 866.3990, within the Microbiology review panel as a Class II device.