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FDA 510(k)

VIRGO(TM) RUBELLA IGG ELISA

K-Number: K873088 · 1987-09-09

ApplicantElectro-Nucleonics Laboratories, Inc.
Decision Date1987-09-09
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIRGO(TM) RUBELLA 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 1987-09-09 under 510(k) number K873088. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIRGO(TM) RUBELLA IGG ELISA?

VIRGO(TM) RUBELLA IGG ELISA is a medical device that received FDA 510(k) clearance on 1987-09-09. The listed applicant is Electro-Nucleonics Laboratories, Inc.. The 510(k) number is K873088.

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

VIRGO(TM) RUBELLA IGG ELISA received FDA 510(k) clearance on 1987-09-09, under 510(k) number K873088.

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

The FDA product code for VIRGO(TM) RUBELLA IGG ELISA is LFX.

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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.

K873925VIRGO(TM) MEASLES IGG ELISAK873617GEMSTAR II SYSTEMK873416MULTI-ACCESS REAGENT DISPENSERK873358GEMENI URIC ACID U.V.K871905TOXOPLASMA GONDII IGG ELISAK870928CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche Diagnostics

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.

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