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FDA 510(k)

Curian HpSA, Curian Analyzer

K-Number: K192817 · 2020-03-13

ApplicantMeridian Bioscience, Inc.
Decision Date2020-03-13
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Curian HpSA, Curian Analyzer is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2020-03-13 under approval number K192817. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Curian HpSA, Curian Analyzer?

Curian HpSA, Curian Analyzer is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K192817.

When was Curian HpSA, Curian Analyzer approved by the FDA?

Curian HpSA, Curian Analyzer received FDA 510(k) clearance on 2020-03-13, under approval number K192817.

What company makes Curian HpSA, Curian Analyzer?

Curian HpSA, Curian Analyzer is manufactured by Meridian Bioscience, Inc..

What is the FDA product code for Curian HpSA, Curian Analyzer?

The FDA product code for Curian HpSA, Curian Analyzer is LYR.

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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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