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FDA 510(k)

Dropper hsCRP High Sensitivity CRP Control

K-Number: K152117 · 2016-04-21

ApplicantQuantimetrix Corporation
Decision Date2016-04-21
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dropper hsCRP High Sensitivity CRP Control is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corporation. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K152117. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dropper hsCRP High Sensitivity CRP Control?

Dropper hsCRP High Sensitivity CRP Control is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Quantimetrix Corporation. The 510(k) number is K152117.

When did Dropper hsCRP High Sensitivity CRP Control receive FDA 510(k) clearance?

Dropper hsCRP High Sensitivity CRP Control received FDA 510(k) clearance on 2016-04-21, under 510(k) number K152117.

Who is the listed applicant for Dropper hsCRP High Sensitivity CRP Control?

The FDA 510(k) record lists Quantimetrix Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dropper hsCRP High Sensitivity CRP Control?

The FDA product code for Dropper hsCRP High Sensitivity CRP Control is JJX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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