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FDA 510(k)

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 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 2021-08-13 under 510(k) 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. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K210858.

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

VITROS Chemistry Products PHBR Slides received FDA 510(k) clearance on 2021-08-13, under 510(k) number K210858.

Who is the listed applicant for VITROS Chemistry Products PHBR 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 PHBR Slides?

The FDA product code for VITROS Chemistry Products PHBR Slides is DLZ.

Other records listing Ortho-Clinical Diagnostics, Inc. 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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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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