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-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)

K-Number: K880885 · 1988-08-30

ApplicantImmuno Concepts, Inc.
Decision Date1988-08-30
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) 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 1988-08-30 under 510(k) number K880885. The device is classified under product code GNP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)?

EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K880885.

When did EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) receive FDA 510(k) clearance?

EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) received FDA 510(k) clearance on 1988-08-30, under 510(k) number K880885.

Who is the listed applicant for EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)?

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 EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)?

The FDA product code for EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) is GNP.

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: GNP)

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.

K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan Bio Pty. , Ltd.K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, 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.

↑