Clearance Summary
BIFURCATED NEEDLE received FDA 510(k) clearance under submission number K874249, sponsored by Allergy Laboratories of Ohio, 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 1987-11-03.
- Submission: K874249
- Applicant / Sponsor: Allergy Laboratories of Ohio, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 1987-11-03
Classification & Regulation
This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.