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FDA 510(k)

VITROS Chemistry Products GLU Slides

K-Number: K163433 · 2017-09-18

ApplicantOrtho Clinical Diagnostics
Decision Date2017-09-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITROS Chemistry Products GLU Slides is a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-09-18 under approval number K163433. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Chemistry Products GLU Slides?

VITROS Chemistry Products GLU Slides is a medical device that received FDA 510(k) clearance on 2017-09-18. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K163433.

When was VITROS Chemistry Products GLU Slides approved by the FDA?

VITROS Chemistry Products GLU Slides received FDA 510(k) clearance on 2017-09-18, under approval number K163433.

What company makes VITROS Chemistry Products GLU Slides?

VITROS Chemistry Products GLU Slides is manufactured by Ortho Clinical Diagnostics.

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

The FDA product code for VITROS Chemistry Products GLU Slides is CGA.

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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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