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FDA 510(k)

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set

K-Number: K181464 · 2018-08-31

ApplicantDiaSorin, Inc.
Decision Date2018-08-31
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2018-08-31 under approval number K181464. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is a medical device that received FDA 510(k) clearance on 2018-08-31. It is manufactured by DiaSorin, Inc.. The 510(k) number is K181464.

When was LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set approved by the FDA?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set received FDA 510(k) clearance on 2018-08-31, under approval number K181464.

What company makes LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set?

The FDA product code for LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set is LYR.

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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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