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)

EBV IGM ELISA TEST

K-Number: K910042 · 1991-02-21

ApplicantGull Laboratories, Inc.
Decision Date1991-02-21
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV IGM ELISA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1991-02-21 under 510(k) number K910042. The device is classified under product code LJN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV IGM ELISA TEST?

EBV IGM ELISA TEST is a medical device that received FDA 510(k) clearance on 1991-02-21. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K910042.

When did EBV IGM ELISA TEST receive FDA 510(k) clearance?

EBV IGM ELISA TEST received FDA 510(k) clearance on 1991-02-21, under 510(k) number K910042.

Who is the listed applicant for EBV IGM ELISA TEST?

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

What is the FDA product code for EBV IGM ELISA TEST?

The FDA product code for EBV IGM ELISA TEST is LJN.

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 Gull 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.

K983541HSV 1+2 IGG ELISA TESTK971857MUMPS IGG ELISA TESTYK962343TOXO IGG ELISA TESTK935730EBNA IGG ELISA TESTK940093EBV-EA(D) IGG ELISA TESTK941046VZV IGG ELISA TEST

View all 57 devices →

Related Devices (Code: LJN)

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.

K123021BIOPLEX 2200 EBV IGM KITBio-Rad LaboratoriesK073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MFocus Diagnostics, Inc.K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.K990977SERAQUEST EB VAC IGMQuest Intl., Inc.K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, 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.

↑