← DeviceClear
HomeDevice Clearances

VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 — Ortho-Clinical Diagnostics, Inc. (510(k) K0

VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 — Ortho-Clinical Diagnostics, Inc. (510(k) K0 is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668; Applicant: Ort

Device nameVITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
ApplicantOrtho-Clinical Diagnostics, Inc.
Clearance track510(k)
Submission numberK061464
DecisionSubstantially Equivalent
Decision date2006-06-15
Date received2006-05-25
Product codeJMO
Device class1
Medical specialtyClinical Chemistry
Applicant locationNY, US
SourceopenFDA device

🔍 Search all device clearances →