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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 a medical device manufactured by Quantimetrix Corporation. It received FDA 510(k) clearance on 2016-04-21 under approval 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. It is manufactured by Quantimetrix Corporation. The 510(k) number is K152117.

When was Dropper hsCRP High Sensitivity CRP Control approved by the FDA?

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

What company makes Dropper hsCRP High Sensitivity CRP Control?

Dropper hsCRP High Sensitivity CRP Control is manufactured by Quantimetrix Corporation.

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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