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 ANTIBODY (IGM)

K-Number: K896594 · 1990-01-16

ApplicantHillcrest Biologicals
Decision Date1990-01-16
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV VCA ANTIBODY (IGM) is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1990-01-16 under 510(k) number K896594. 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 VCA ANTIBODY (IGM)?

EBV VCA ANTIBODY (IGM) is a medical device that received FDA 510(k) clearance on 1990-01-16. The listed applicant is Hillcrest Biologicals. The 510(k) number is K896594.

When did EBV VCA ANTIBODY (IGM) receive FDA 510(k) clearance?

EBV VCA ANTIBODY (IGM) received FDA 510(k) clearance on 1990-01-16, under 510(k) number K896594.

Who is the listed applicant for EBV VCA ANTIBODY (IGM)?

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

What is the FDA product code for EBV VCA ANTIBODY (IGM)?

The FDA product code for EBV VCA ANTIBODY (IGM) 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 Hillcrest Biologicals 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.

K913618ARBOVIRUS IGM IFA TESTK913617ARBOVIRUS IGG IFA TESTK922374Q FEVER IGM IFA TESTK913906Q FEVER IGG IFA TESTK900206LYME DISEASE IGM ELISAK884829EBV EARLY ANTIGEN (R+D)

View all 33 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.

↑