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)

LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM

K-Number: K082050 · 2008-11-03

ApplicantDiaSorin, Inc.
Decision Date2008-11-03
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2008-11-03 under 510(k) number K082050. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM?

LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM is a medical device that received FDA 510(k) clearance on 2008-11-03. The listed applicant is DiaSorin, Inc.. The 510(k) number is K082050.

When did LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM receive FDA 510(k) clearance?

LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM received FDA 510(k) clearance on 2008-11-03, under 510(k) number K082050.

Who is the listed applicant for LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM?

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

What is the FDA product code for LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM?

The FDA product code for LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM is LOL.

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 DiaSorin, 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.

K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXK231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTK223403LIAISON Anti-HAV; LIAISON XSK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusK213936LIAISON MeMed BV, LIAISON MeMed BV Control SetK193650LIAISON Ferritin

View all 66 devices →

Related Devices (Code: LOL)

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.

K260048Elecsys Anti-HAV IgMRoche DiagnosticsK251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott LaboratoriesK223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc.K210272LIAISON Anti-HAVDiaSorin, 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.

↑