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FDA 510(k)

HEPATIQ 1.1

K-Number: K161188 · 2016-06-09

ApplicantHepatiq, LLC
Decision Date2016-06-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HEPATIQ 1.1 is a medical device manufactured by Hepatiq, LLC. It received FDA 510(k) clearance on 2016-06-09 under approval number K161188. 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 HEPATIQ 1.1?

HEPATIQ 1.1 is a medical device that received FDA 510(k) clearance on 2016-06-09. It is manufactured by Hepatiq, LLC. The 510(k) number is K161188.

When was HEPATIQ 1.1 approved by the FDA?

HEPATIQ 1.1 received FDA 510(k) clearance on 2016-06-09, under approval number K161188.

What company makes HEPATIQ 1.1?

HEPATIQ 1.1 is manufactured by Hepatiq, LLC.

What is the FDA product code for HEPATIQ 1.1?

The FDA product code for HEPATIQ 1.1 is LLZ.

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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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