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FDA 510(k)

IMMUNOWELL EBV VCA IGG TEST

K-Number: K973940 · 1998-08-10

ApplicantGenbio
Decision Date1998-08-10
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOWELL EBV VCA IGG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genbio. It received FDA 510(k) clearance on 1998-08-10 under 510(k) number K973940. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOWELL EBV VCA IGG TEST?

IMMUNOWELL EBV VCA IGG TEST is a medical device that received FDA 510(k) clearance on 1998-08-10. The listed applicant is Genbio. The 510(k) number is K973940.

When did IMMUNOWELL EBV VCA IGG TEST receive FDA 510(k) clearance?

IMMUNOWELL EBV VCA IGG TEST received FDA 510(k) clearance on 1998-08-10, under 510(k) number K973940.

Who is the listed applicant for IMMUNOWELL EBV VCA IGG TEST?

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

What is the FDA product code for IMMUNOWELL EBV VCA IGG TEST?

The FDA product code for IMMUNOWELL EBV VCA IGG TEST is LSE.

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Other records listing Genbio 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.

K010301IMMUNOWELL EA (D) IGG TESTK974226IMMUNODOT MONO-G TESTK974244IMMUNODOT MONO-M TESTK973939IMMUNOWELL VCA IGM TESTK973941IMMUNOWELL EBNA IGG TESTK963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)

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Related Devices (Code: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad 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.

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