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FDA 510(k)

VITROS Chemistry Products Cl- Slides

K-Number: K162020 · 2016-12-16

ApplicantOrtho Clinical Diagnostics
Decision Date2016-12-16
Product CodeCGZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Chemistry Products Cl- Slides is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K162020. 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 Cl- Slides is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K162020.

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

VITROS Chemistry Products Cl- Slides received FDA 510(k) clearance on 2016-12-16, under 510(k) number K162020.

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

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

What is the FDA product code for VITROS Chemistry Products Cl- Slides?

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

Other records listing Ortho Clinical Diagnostics 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.

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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.

K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.K170320Alinity c ICT Sample DiluentAbbott Laboratories

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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