K191316

Substantially Equivalent

VITROS XT Chemistry Products ALB-TP Slides

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: CIX
Advisory panel: Clinical Chemistry
Date received: 2019-05-15
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.