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)

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM

K-Number: K951495 · 1995-12-20

ApplicantBio-Rad Laboratories, Inc.
Decision Date1995-12-20
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1995-12-20 under 510(k) number K951495. 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 ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM?

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-12-20. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K951495.

When did ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1995-12-20, under 510(k) number K951495.

Who is the listed applicant for ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM?

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

What is the FDA product code for ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM?

The FDA product code for ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM 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 Bio-Rad Laboratories, 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.

K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemK171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareK161687D-10 Hemoglobin A1c ProgramK130053BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BIK130963LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAKK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK

View all 79 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.

↑