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 PLATINUM HPSA

K-Number: K980076 · 1998-05-12

ApplicantMeridian Diagnostics, Inc.
Decision Date1998-05-12
Product CodeLYR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER PLATINUM HPSA is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K980076. 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?

PREMIER PLATINUM HPSA is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K980076.

When did PREMIER PLATINUM HPSA receive FDA 510(k) clearance?

PREMIER PLATINUM HPSA received FDA 510(k) clearance on 1998-05-12, under 510(k) number K980076.

Who is the listed applicant for PREMIER PLATINUM HPSA?

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

What is the FDA product code for PREMIER PLATINUM HPSA?

The FDA product code for PREMIER PLATINUM HPSA is LYR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Meridian Diagnostics, 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.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

View all 92 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.K230901Premier HpSA Flex (619096)Meridian Bioscience, 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.

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.

↑