Clearance Summary
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) received FDA 510(k) clearance under submission number K973510, sponsored by Immuno-U.S., 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 1997-12-08.
- Submission: K973510
- Applicant / Sponsor: Immuno-U.S., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 1997-12-08
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.