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FDA 510(k)

LIAISON CMV IgM Serum Control Set

K-Number: K161526 · 2016-06-30

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

Device Summary

LIAISON CMV 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 K161526. 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 CMV IgM Serum Control Set?

LIAISON CMV 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 K161526.

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

LIAISON CMV IgM Serum Control Set received FDA 510(k) clearance on 2016-06-30, under approval number K161526.

What company makes LIAISON CMV IgM Serum Control Set?

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

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

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

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Other Devices by DiaSorin, Inc.

K160650LIAISON HAV IgM, LIAISON Control HAV IgM K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set K161522LIAISON EBV IgM Serum Control Set K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

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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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