Clearance Summary
ATI DISPOSABLE BIOLOGICAL TEST PACK received FDA 510(k) clearance under submission number K855120, sponsored by Parke-Davis Co.. 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 1986-06-18.
- Submission: K855120
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1986-06-18
Classification & Regulation
This clearance is catalogued under FDA product code FRC and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.