Clearance Summary
IP SPECIFIC E received FDA 510(k) clearance under submission number K821094, sponsored by Diagnostic Reagent Tech.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1982-05-07.
- Submission: K821094
- Applicant / Sponsor: Diagnostic Reagent Tech.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 1982-05-07
Classification & Regulation
This clearance is catalogued under FDA product code DGO and 21 CFR 866.5510, within the Immunology review panel as a Class II device.