FDA 510(k)

HEPATIQ 1.1

K-Number: K161188 · 2016-06-09

Decision Date2016-06-09

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HEPATIQ 1.1 is the device name listed in this FDA 510(k) record. The listed applicant is Hepatiq, LLC. It received FDA 510(k) clearance on 2016-06-09 under 510(k) 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. The listed applicant is Hepatiq, LLC. The 510(k) number is K161188.

When did HEPATIQ 1.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for HEPATIQ 1.1?

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

What is the FDA product code for HEPATIQ 1.1?

The FDA product code for HEPATIQ 1.1 is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.