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FDA 510(k)

PREMIER Platinum HpSA PLUS

K-Number: K182559 · 2018-11-05

ApplicantMeridian Bioscience, Inc.
Decision Date2018-11-05
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER Platinum HpSA PLUS is a medical device manufactured by Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2018-11-05 under approval number K182559. 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 Platinum HpSA PLUS?

PREMIER Platinum HpSA PLUS is a medical device that received FDA 510(k) clearance on 2018-11-05. It is manufactured by Meridian Bioscience, Inc.. The 510(k) number is K182559.

When was PREMIER Platinum HpSA PLUS approved by the FDA?

PREMIER Platinum HpSA PLUS received FDA 510(k) clearance on 2018-11-05, under approval number K182559.

What company makes PREMIER Platinum HpSA PLUS?

PREMIER Platinum HpSA PLUS is manufactured by Meridian Bioscience, Inc..

What is the FDA product code for PREMIER Platinum HpSA PLUS?

The FDA product code for PREMIER Platinum HpSA PLUS is LYR.

Related Clinical Trials

NCT03273023 PROMUS PREMIER™ China Post-Approval Study COMPLETED

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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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