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)

FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS

K-Number: K912488 · 1991-07-24

ApplicantImmuno Concepts, Inc.
Decision Date1991-07-24
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1991-07-24 under 510(k) number K912488. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS?

FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K912488.

When did FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS receive FDA 510(k) clearance?

FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912488.

Who is the listed applicant for FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS?

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

What is the FDA product code for FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS?

The FDA product code for FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS is LSE.

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 Immuno Concepts, 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.

K013432IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040GK013283RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16K013285RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15K992041RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-ROK972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM

View all 36 devices →

Related Devices (Code: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, 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.

↑