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FDA 510(k)

Premier HpSA Flex (619096)

K-Number: K230901 · 2023-07-03

ApplicantMeridian Bioscience, Inc.
Decision Date2023-07-03
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Premier HpSA Flex (619096) is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-07-03 under approval number K230901. 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 Premier HpSA Flex (619096)?

Premier HpSA Flex (619096) is a medical device that received FDA 510(k) clearance on 2023-07-03. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K230901.

When was Premier HpSA Flex (619096) approved by the FDA?

Premier HpSA Flex (619096) received FDA 510(k) clearance on 2023-07-03, under approval number K230901.

What company makes Premier HpSA Flex (619096)?

Premier HpSA Flex (619096) is manufactured by Meridian Bioscience, Inc..

What is the FDA product code for Premier HpSA Flex (619096)?

The FDA product code for Premier HpSA Flex (619096) 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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