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FDA 510(k)

LIAISON HAV IgM, LIAISON Control HAV IgM

K-Number: K160650 · 2016-08-25

ApplicantDiaSorin, Inc.
Decision Date2016-08-25
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON HAV IgM, LIAISON Control HAV IgM is a medical device manufactured by DiaSorin, Inc.. It received FDA 510(k) clearance on 2016-08-25 under approval number K160650. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON HAV IgM, LIAISON Control HAV IgM?

LIAISON HAV IgM, LIAISON Control HAV IgM is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by DiaSorin, Inc.. The 510(k) number is K160650.

When was LIAISON HAV IgM, LIAISON Control HAV IgM approved by the FDA?

LIAISON HAV IgM, LIAISON Control HAV IgM received FDA 510(k) clearance on 2016-08-25, under approval number K160650.

What company makes LIAISON HAV IgM, LIAISON Control HAV IgM?

LIAISON HAV IgM, LIAISON Control HAV IgM is manufactured by DiaSorin, Inc..

What is the FDA product code for LIAISON HAV IgM, LIAISON Control HAV IgM?

The FDA product code for LIAISON HAV IgM, LIAISON Control HAV IgM is LOL.

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Related Devices (Code: LOL)

K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. K190428Elecsys Anti-HAV IIRoche Diagnostics K193532LIAISON Anti-HAV AssayDiaSorin, Inc. K210272LIAISON Anti-HAVDiaSorin, Inc. K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc. K222850HAVAb IgG IIAbbott Laboratories

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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