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FDA 510(k)

VITROS Chemistry Products hsCRP Reagent

K-Number: K160712 · 2017-07-14

ApplicantOrtho Clinical Diagnostics
Decision Date2017-07-14
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

VITROS Chemistry Products hsCRP Reagent 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 2017-07-14 under 510(k) number K160712. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITROS Chemistry Products hsCRP Reagent?

VITROS Chemistry Products hsCRP Reagent is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Ortho Clinical Diagnostics. The 510(k) number is K160712.

When did VITROS Chemistry Products hsCRP Reagent receive FDA 510(k) clearance?

VITROS Chemistry Products hsCRP Reagent received FDA 510(k) clearance on 2017-07-14, under 510(k) number K160712.

Who is the listed applicant for VITROS Chemistry Products hsCRP Reagent?

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 hsCRP Reagent?

The FDA product code for VITROS Chemistry Products hsCRP Reagent is DCK.

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Related Devices (Code: DCK)

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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