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)

IMMUNOWELL EBNA IGG TEST

K-Number: K973941 · 1998-08-10

ApplicantGenbio
Decision Date1998-08-10
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOWELL EBNA IGG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genbio. It received FDA 510(k) clearance on 1998-08-10 under 510(k) number K973941. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOWELL EBNA IGG TEST?

IMMUNOWELL EBNA IGG TEST is a medical device that received FDA 510(k) clearance on 1998-08-10. The listed applicant is Genbio. The 510(k) number is K973941.

When did IMMUNOWELL EBNA IGG TEST receive FDA 510(k) clearance?

IMMUNOWELL EBNA IGG TEST received FDA 510(k) clearance on 1998-08-10, under 510(k) number K973941.

Who is the listed applicant for IMMUNOWELL EBNA IGG TEST?

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

What is the FDA product code for IMMUNOWELL EBNA IGG TEST?

The FDA product code for IMMUNOWELL EBNA IGG TEST is LLM.

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 Genbio 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.

K010301IMMUNOWELL EA (D) IGG TESTK974226IMMUNODOT MONO-G TESTK974244IMMUNODOT MONO-M TESTK973939IMMUNOWELL VCA IGM TESTK973940IMMUNOWELL EBV VCA IGG TESTK963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)

View all 10 devices →

Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, Inc.K951822EBNA ENZYME IMMUNOASSAY KITGranbio, 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.

↑