Clearance Summary
Oryum and Ovem Epidermal Deri Prick Test Applicator received FDA 510(k) clearance under submission number K182582, sponsored by Allergy & Applicator Depot, LLC. 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 2019-04-10.
- Submission: K182582
- Applicant / Sponsor: Allergy & Applicator Depot, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2019-04-10
Classification & Regulation
This clearance is catalogued under FDA product code SCL and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.