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)

ROTAVIRUS EIA

K-Number: K964424 · 1997-08-08

ApplicantTrinity Biotech, Inc.
Decision Date1997-08-08
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTAVIRUS EIA is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Biotech, Inc.. It received FDA 510(k) clearance on 1997-08-08 under 510(k) number K964424. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTAVIRUS EIA?

ROTAVIRUS EIA is a medical device that received FDA 510(k) clearance on 1997-08-08. The listed applicant is Trinity Biotech, Inc.. The 510(k) number is K964424.

When did ROTAVIRUS EIA receive FDA 510(k) clearance?

ROTAVIRUS EIA received FDA 510(k) clearance on 1997-08-08, under 510(k) number K964424.

Who is the listed applicant for ROTAVIRUS EIA?

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

What is the FDA product code for ROTAVIRUS EIA?

The FDA product code for ROTAVIRUS EIA is LIQ.

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 Trinity Biotech, 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.

K033059HERPES GROUP IGG

Related Devices (Code: LIQ)

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.

K990842SAS ROTA TESTSa Scientific, Inc.K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.K942286DIARLEX ROTA-ADENOOrion Diagnostica, 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.

↑