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 EARLY ANTIGEN (R+D)

K-Number: K884829 · 1989-04-12

ApplicantHillcrest Biologicals
Decision Date1989-04-12
Product CodeJRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV EARLY ANTIGEN (R+D) is the device name listed in this FDA 510(k) record. The listed applicant is Hillcrest Biologicals. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K884829. The device is classified under product code JRY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBV EARLY ANTIGEN (R+D)?

EBV EARLY ANTIGEN (R+D) is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Hillcrest Biologicals. The 510(k) number is K884829.

When did EBV EARLY ANTIGEN (R+D) receive FDA 510(k) clearance?

EBV EARLY ANTIGEN (R+D) received FDA 510(k) clearance on 1989-04-12, under 510(k) number K884829.

Who is the listed applicant for EBV EARLY ANTIGEN (R+D)?

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 EARLY ANTIGEN (R+D)?

The FDA product code for EBV EARLY ANTIGEN (R+D) is JRY.

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 TESTK913906Q FEVER IGG IFA TESTK922374Q FEVER IGM IFA TESTK900206LYME DISEASE IGM ELISAK896594EBV VCA ANTIBODY (IGM)

View all 33 devices →

Related Devices (Code: JRY)

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.

K042118ATHENA MULTI-LYTE EBV IGG TEST SYSTEMZeus Scientific, Inc.K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.Stellar Bio Systems, Inc.K891785BION EBV-G (VCA) TEST SYSTEMBion Ent., Ltd.K822734EBV IGM TESTGull Laboratories, Inc.K822985EBV-M KITLitton BioneticsK821849EBV-VCA ANTIBODY ASSAY KITBiotech Research 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.

↑