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FDA 510(k)

ADVIA Centaur HAV IgM Assay

K-Number: K161964 · 2016-10-13

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-10-13
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur HAV IgM Assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-10-13 under approval number K161964. 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 ADVIA Centaur HAV IgM Assay?

ADVIA Centaur HAV IgM Assay is a medical device that received FDA 510(k) clearance on 2016-10-13. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K161964.

When was ADVIA Centaur HAV IgM Assay approved by the FDA?

ADVIA Centaur HAV IgM Assay received FDA 510(k) clearance on 2016-10-13, under approval number K161964.

What company makes ADVIA Centaur HAV IgM Assay?

ADVIA Centaur HAV IgM Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for ADVIA Centaur HAV IgM Assay?

The FDA product code for ADVIA Centaur HAV IgM Assay is LOL.

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Related Devices (Code: LOL)

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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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