Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 received FDA 510(k) clearance under submission number K060632, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-06-06.
- Submission: K060632
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1117
- Decision date: 2006-06-06
Classification & Regulation
This clearance is catalogued under FDA product code NBC and 21 CFR 862.1117, within the Clinical Chemistry review panel as a Class II device.