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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 the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2018-11-05 under 510(k) 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. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K182559.

When did PREMIER Platinum HpSA PLUS receive FDA 510(k) clearance?

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

Who is the listed applicant for PREMIER Platinum HpSA PLUS?

The FDA 510(k) record lists Meridian Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Meridian Bioscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243922RevogeneK230901Premier HpSA Flex (619096)K222829Curian® Shiga ToxinK222779RevogeneK220480RevogeneK210976Curian Campy

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Related Devices (Code: LYR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.K181400H. PYLORI CHEK™Techlab, Inc.

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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