Clearance Summary
VITROS Immunodiagnostic Products CK-MB Reagent Pack received FDA 510(k) clearance under submission number K212648, sponsored by Ortho Clinical Diagnostics. 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 2022-01-28.
- Submission: K212648
- Applicant / Sponsor: Ortho Clinical Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2022-01-28
Classification & Regulation
This clearance is catalogued under FDA product code JHX and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.