VITROS® Automation Solutions
K-Number: K160495 · 2016-10-18
ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2016-10-18
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
VITROS® Automation Solutions is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-10-18 under approval number K160495. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VITROS® Automation Solutions?
VITROS® Automation Solutions is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K160495.
When was VITROS® Automation Solutions approved by the FDA?
VITROS® Automation Solutions received FDA 510(k) clearance on 2016-10-18, under approval number K160495.
What company makes VITROS® Automation Solutions?
VITROS® Automation Solutions is manufactured by Ortho-Clinical Diagnostics, Inc..
What is the FDA product code for VITROS® Automation Solutions?
The FDA product code for VITROS® Automation Solutions is KLI.
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K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
K191316VITROS XT Chemistry Products ALB-TP Slides
K190807VITROS XT Chemistry Products TBIL-ALKP Slides
K190520VITROS XT Chemistry Products GLU-Ca Slides
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.