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 a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2016-12-16 under approval 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. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K162020.
When was VITROS Chemistry Products Cl- Slides approved by the FDA?
VITROS Chemistry Products Cl- Slides received FDA 510(k) clearance on 2016-12-16, under approval number K162020.
What company makes VITROS Chemistry Products Cl- Slides?
VITROS Chemistry Products Cl- Slides is manufactured by Ortho Clinical Diagnostics.
What is the FDA product code for VITROS Chemistry Products Cl- Slides?
The FDA product code for VITROS Chemistry Products Cl- Slides is CGZ.
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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.