Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS received FDA 510(k) clearance under submission number K060770, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2006-09-15.
- Submission: K060770
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3310
- Decision date: 2006-09-15
Classification & Regulation
This clearance is catalogued under FDA product code LOL and 21 CFR 866.3310, within the Microbiology review panel as a Class II device.