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FDA 510(k)

LIAISON EBV IgM Serum Control Set

K-Number: K161522 · 2016-06-30

ApplicantDiaSorin, Inc.
Decision Date2016-06-30
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIAISON EBV IgM Serum Control Set is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-06-30 under approval number K161522. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON EBV IgM Serum Control Set?

LIAISON EBV IgM Serum Control Set is a medical device that received FDA 510(k) clearance on 2016-06-30. It is manufactured by DiaSorin, Inc.. The 510(k) number is K161522.

When was LIAISON EBV IgM Serum Control Set approved by the FDA?

LIAISON EBV IgM Serum Control Set received FDA 510(k) clearance on 2016-06-30, under approval number K161522.

What company makes LIAISON EBV IgM Serum Control Set?

LIAISON EBV IgM Serum Control Set is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON EBV IgM Serum Control Set?

The FDA product code for LIAISON EBV IgM Serum Control Set is JJX.

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Other Devices by DiaSorin, Inc.

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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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