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FDA 510(k)

VITROS XT Chemistry Products ALB-TP Slides

K-Number: K191316 · 2019-06-07

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2019-06-07
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS XT Chemistry Products ALB-TP Slides 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 2019-06-07 under 510(k) number K191316. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS XT Chemistry Products ALB-TP Slides?

VITROS XT Chemistry Products ALB-TP Slides is a medical device that received FDA 510(k) clearance on 2019-06-07. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K191316.

When did VITROS XT Chemistry Products ALB-TP Slides receive FDA 510(k) clearance?

VITROS XT Chemistry Products ALB-TP Slides received FDA 510(k) clearance on 2019-06-07, under 510(k) number K191316.

Who is the listed applicant for VITROS XT Chemistry Products ALB-TP Slides?

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 XT Chemistry Products ALB-TP Slides?

The FDA product code for VITROS XT Chemistry Products ALB-TP Slides is CIX.

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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.

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