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)

ADVIA CENTAUR HAVM ASSAY

K-Number: K081716 · 2008-07-17

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2008-07-17
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR HAVM ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-07-17 under 510(k) number K081716. 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 ADVIA CENTAUR HAVM ASSAY?

ADVIA CENTAUR HAVM ASSAY is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K081716.

When did ADVIA CENTAUR HAVM ASSAY receive FDA 510(k) clearance?

ADVIA CENTAUR HAVM ASSAY received FDA 510(k) clearance on 2008-07-17, under 510(k) number K081716.

Who is the listed applicant for ADVIA CENTAUR HAVM ASSAY?

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

What is the FDA product code for ADVIA CENTAUR HAVM ASSAY?

The FDA product code for ADVIA CENTAUR HAVM ASSAY 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 Siemens Healthcare 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.

K253528Atellica IM CA 19-9 IIK261364Atellica CH Acetaminophen 2 (ACTM)K251998Atellica CH Diazo Total Bilirubin (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630Atellica IM Total PSA II (tPSAII)K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)

View all 114 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.

↑