Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience, Inc.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) 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. The listed applicant is Meridian Bioscience, Inc.. The 510(k) number is K230901.

When did Premier HpSA Flex (619096) receive FDA 510(k) clearance?

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

Who is the listed applicant for Premier HpSA Flex (619096)?

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 HpSA Flex (619096)?

The FDA product code for Premier HpSA Flex (619096) 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.

K243922RevogeneK222829Curian® Shiga ToxinK222779RevogeneK220480RevogeneK210976Curian CampyPMA P100025Test, urea adult and pediatric (breath),

View all 12 devices →

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.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, 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.

↑