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)

VIRGO(TM) MEASLES IGG ELISA

K-Number: K873925 · 1988-02-24

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1988-02-24
Product CodeLJB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRGO(TM) MEASLES IGG ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Nucleonics Laboratories, Inc.. It received FDA 510(k) clearance on 1988-02-24 under 510(k) number K873925. The device is classified under product code LJB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO(TM) MEASLES IGG ELISA?

VIRGO(TM) MEASLES IGG ELISA is a medical device that received FDA 510(k) clearance on 1988-02-24. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K873925.

When did VIRGO(TM) MEASLES IGG ELISA receive FDA 510(k) clearance?

VIRGO(TM) MEASLES IGG ELISA received FDA 510(k) clearance on 1988-02-24, under 510(k) number K873925.

Who is the listed applicant for VIRGO(TM) MEASLES IGG ELISA?

The FDA 510(k) record lists Electro-Nucleonics Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIRGO(TM) MEASLES IGG ELISA?

The FDA product code for VIRGO(TM) MEASLES IGG ELISA is LJB.

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 Electro-Nucleonics Laboratories, 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.

K873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K873088VIRGO(TM) RUBELLA IGG ELISAK871905TOXOPLASMA GONDII IGG ELISAK870928CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS

View all 41 devices →

Related Devices (Code: LJB)

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.

K974552DIAMEDIX IS-MEASLES IGG TEST SYSTEMDiamedix Corp.K971620QUANTA LITE RUBEOLA (MEASLES) IGGInova Diagnostics, Inc.K922330BARTELS RUBEOLA IGG EIABaxter Diagnostics, Inc.K922335BARTELS RUBEOLA IGM EIABaxter Diagnostics, Inc.K910290VIRATEST-DIA(TM) MEASLES (RUBEOLA)Virus Reference Laboratory, Inc.K904083RUBEOLA IGM ELISA TESTGull 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.

↑