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FDA 510(k)

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set

K-Number: K192046 · 2019-10-28

ApplicantDiaSorin, Inc.
Decision Date2019-10-28
Product CodeQFO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2019-10-28 under approval number K192046. The device is classified under product code QFO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is a medical device that received FDA 510(k) clearance on 2019-10-28. It is manufactured by DiaSorin, Inc.. The 510(k) number is K192046.

When was LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set approved by the FDA?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set received FDA 510(k) clearance on 2019-10-28, under approval number K192046.

What company makes LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set?

The FDA product code for LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set is QFO.

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Related Devices (Code: QFO)

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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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