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FDA 510(k)

QuantX

K-Number: K170195 · 2017-05-17

ApplicantQuantitative Insights, Inc.
Decision Date2017-05-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QuantX is a medical device manufactured by Quantitative Insights, Inc.. It received FDA 510(k) clearance on 2017-05-17 under approval number K170195. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuantX?

QuantX is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by Quantitative Insights, Inc.. The 510(k) number is K170195.

When was QuantX approved by the FDA?

QuantX received FDA 510(k) clearance on 2017-05-17, under approval number K170195.

What company makes QuantX?

QuantX is manufactured by Quantitative Insights, Inc..

What is the FDA product code for QuantX?

The FDA product code for QuantX is LLZ.

Other Devices by Quantitative Insights, Inc.

DEN170022QuantX

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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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