Clearance Summary
ALLER-SCREEN SKIN TEST KIT received FDA 510(k) clearance under submission number K791328, sponsored by Aller-Screen, Inc.. 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 1980-05-30.
- Submission: K791328
- Applicant / Sponsor: Aller-Screen, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1980-05-30
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.