Clearance Summary
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK ; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS received FDA 510(k) clearance under submission number K993068, sponsored by Ortho-Clinical Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1999-10-04.
- Submission: K993068
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1999-10-04
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.