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)

PHASE II GBM IGG ANTIBODY EIA TEST

K-Number: K011348 · 2001-06-25

ApplicantScimedx Corp.
Decision Date2001-06-25
Product CodeMVJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PHASE II GBM 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 2001-06-25 under 510(k) number K011348. The device is classified under product code MVJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASE II GBM IGG ANTIBODY EIA TEST?

PHASE II GBM IGG ANTIBODY EIA TEST is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Scimedx Corp.. The 510(k) number is K011348.

When did PHASE II GBM IGG ANTIBODY EIA TEST receive FDA 510(k) clearance?

PHASE II GBM IGG ANTIBODY EIA TEST received FDA 510(k) clearance on 2001-06-25, under 510(k) number K011348.

Who is the listed applicant for PHASE II GBM 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 PHASE II GBM IGG ANTIBODY EIA TEST?

The FDA product code for PHASE II GBM IGG ANTIBODY EIA TEST is MVJ.

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.

K011082TPO 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: MVJ)

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.

K071219ATHENA MULTI-LYTE GBM TEST SYSTEMZeus Scientific, Inc.K072358BIOPLEX VASCULITIS KITBio-Rad LaboratoriesK991890AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISACogent Diagnotics , Ltd.K984619BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.K984336QUANTA LITE GBM ELISAInova Diagnostics, 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.

↑