VITROS Chemistry Products PHBR Slides
K-Number: K210858 · 2021-08-13
ApplicantOrtho-Clinical Diagnostics, Inc.
Decision Date2021-08-13
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent
Device Summary
VITROS Chemistry Products PHBR Slides is a medical device manufactured by Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-08-13 under approval number K210858. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VITROS Chemistry Products PHBR Slides?
VITROS Chemistry Products PHBR Slides is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K210858.
When was VITROS Chemistry Products PHBR Slides approved by the FDA?
VITROS Chemistry Products PHBR Slides received FDA 510(k) clearance on 2021-08-13, under approval number K210858.
What company makes VITROS Chemistry Products PHBR Slides?
VITROS Chemistry Products PHBR Slides is manufactured by Ortho-Clinical Diagnostics, Inc..
What is the FDA product code for VITROS Chemistry Products PHBR Slides?
The FDA product code for VITROS Chemistry Products PHBR Slides is DLZ.
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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.