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FDA 510(k)

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides

K-Number: K182072 · 2018-10-30

ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2018-10-30
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU 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 2018-10-30 under 510(k) number K182072. The device is classified under product code CGZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides?

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K182072.

When did VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides receive FDA 510(k) clearance?

VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182072.

Who is the listed applicant for VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU 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 Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides?

The FDA product code for VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides is CGZ.

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

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Related Devices (Code: CGZ)

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.

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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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