Clearance Summary
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE received FDA 510(k) clearance under submission number DEN120001, sponsored by Phadia US, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2012-02-15.
- Submission: DEN120001
- Applicant / Sponsor: Phadia US, Inc.
- Clearance pathway: Post-NSE
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5760
- Decision date: 2012-02-15
Classification & Regulation
This clearance is catalogued under FDA product code OYL and 21 CFR 866.5760, within the Immunology review panel as a Class II device.