Clearance Summary
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, received FDA 510(k) clearance under submission number K123593, sponsored by Inova Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2013-04-17.
- Submission: K123593
- Applicant / Sponsor: Inova Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2013-04-17
Classification & Regulation
This clearance is catalogued under FDA product code LKP and 21 CFR 866.5100, within the Immunology review panel as a Class II device.