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 TOXOPLASMA IGG (TOXO G)

K-Number: K102681 · 2011-05-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2011-05-04
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) 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 2011-05-04 under 510(k) number K102681. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)?

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) is a medical device that received FDA 510(k) clearance on 2011-05-04. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K102681.

When did ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) receive FDA 510(k) clearance?

ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) received FDA 510(k) clearance on 2011-05-04, under 510(k) number K102681.

Who is the listed applicant for ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)?

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 TOXOPLASMA IGG (TOXO G)?

The FDA product code for ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) is LGD.

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: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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.

↑