Clearance Summary
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls received FDA 510(k) clearance under submission number K161899, sponsored by Phadia AB. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-07-28.
- Submission: K161899
- Applicant / Sponsor: Phadia AB
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2016-07-28
Classification & Regulation
This clearance is catalogued under FDA product code DGC and 21 CFR 866.5510, within the Immunology review panel as a Class II device.