Clearance Summary
HMB ALLERGOGEN SKIN PRICK TEST NEEDLE received FDA 510(k) clearance under submission number K844221, sponsored by Aller/Guard, 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 1985-02-08.
- Submission: K844221
- Applicant / Sponsor: Aller/Guard, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1985-02-08
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.