Clearance Summary
INFLAMMA DRY received FDA 510(k) clearance under submission number K132066, sponsored by Rapid Pathogen Screening, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2013-11-21.
- Submission: K132066
- Applicant / Sponsor: Rapid Pathogen Screening, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1540
- Decision date: 2013-11-21
Classification & Regulation
This clearance is catalogued under FDA product code PFQ and 21 CFR 862.1540, within the Clinical Chemistry review panel as a Class I device.