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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 a medical device manufactured by Ortho Clinical Diagnostics. It received FDA 510(k) clearance on 2017-07-14 under approval 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. It is manufactured by Ortho Clinical Diagnostics. The 510(k) number is K160712.

When was VITROS Chemistry Products hsCRP Reagent approved by the FDA?

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

What company makes VITROS Chemistry Products hsCRP Reagent?

VITROS Chemistry Products hsCRP Reagent is manufactured by Ortho Clinical Diagnostics.

What is the FDA product code for VITROS Chemistry Products hsCRP Reagent?

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

Other Devices by Ortho Clinical Diagnostics

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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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