Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-10-18 under 510(k) 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. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K160495.

When did VITROS® Automation Solutions receive FDA 510(k) clearance?

VITROS® Automation Solutions received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160495.

Who is the listed applicant for VITROS® Automation Solutions?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS® Automation Solutions?

The FDA product code for VITROS® Automation Solutions is KLI.

Other records listing Ortho-Clinical Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackK241534VITROS Immunodiagnostic Products Syphilis Reagent PackK233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackK221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackK231517VITROS Immunodiagnostic Products CEA Reagent PackK231525VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack

View all 32 devices →

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.

↑