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)

TPO IGG ANTIBODY EIA TEST

K-Number: K011082 · 2001-06-06

ApplicantScimedx Corp.
Decision Date2001-06-06
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TPO IGG ANTIBODY EIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Scimedx Corp.. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K011082. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TPO IGG ANTIBODY EIA TEST?

TPO IGG ANTIBODY EIA TEST is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Scimedx Corp.. The 510(k) number is K011082.

When did TPO IGG ANTIBODY EIA TEST receive FDA 510(k) clearance?

TPO IGG ANTIBODY EIA TEST received FDA 510(k) clearance on 2001-06-06, under 510(k) number K011082.

Who is the listed applicant for TPO IGG ANTIBODY EIA TEST?

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

What is the FDA product code for TPO IGG ANTIBODY EIA TEST?

The FDA product code for TPO IGG ANTIBODY EIA TEST is JZO.

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 Scimedx Corp. 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.

K011348PHASE II GBM IGG ANTIBODY EIA TESTK010625EUROSPITAL EU-TTG IGA UMANAK010287SCIMEDX PHASE II PR3 IGG ANTIBODY EIAK010289SCIMEDX PHASE II MPO IGG ANTIBODY EIAK002189GLIADIN IGG ANTIBODY EIA DETECTION SYSTEMK002169GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

View all 14 devices →

Related Devices (Code: JZO)

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.

K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc.K240469Access TPO AntibodyBeckman Coulter, Inc.K213517Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K222610Elecsys Anti-TgRoche DiagnosticsK193313Elecsys Anti-TSHRRoche DiagnosticsK151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000Phadia AB

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.

↑