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)

HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS

K-Number: K920222 · 1992-07-27

ApplicantAkers Research Corp.
Decision Date1992-07-27
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Akers Research Corp.. It received FDA 510(k) clearance on 1992-07-27 under 510(k) number K920222. The device is classified under product code LJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS?

HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS is a medical device that received FDA 510(k) clearance on 1992-07-27. The listed applicant is Akers Research Corp.. The 510(k) number is K920222.

When did HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS receive FDA 510(k) clearance?

HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS received FDA 510(k) clearance on 1992-07-27, under 510(k) number K920222.

Who is the listed applicant for HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS?

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

What is the FDA product code for HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS?

The FDA product code for HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS is LJO.

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 Akers Research Corp. 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.

K920221HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAYK920220HEALTHTEST RHEUMATOID FACTOR ASSAY

Related Devices (Code: LJO)

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.

K203612Capture-CMVImmucor, Inc.K183571Capture-CMVImmucor, Inc.K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.K974901HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.K974456CMVGENInstrumentation Laboratory COK951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., 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.

↑