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FDA 510(k)

IMMUNODOT MONO-G TEST

K-Number: K974226 · 1998-09-22

ApplicantGenbio
Decision Date1998-09-22
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNODOT MONO-G TEST is the device name listed in this FDA 510(k) record. The listed applicant is Genbio. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K974226. 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 IMMUNODOT MONO-G TEST?

IMMUNODOT MONO-G TEST is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Genbio. The 510(k) number is K974226.

When did IMMUNODOT MONO-G TEST receive FDA 510(k) clearance?

IMMUNODOT MONO-G TEST received FDA 510(k) clearance on 1998-09-22, under 510(k) number K974226.

Who is the listed applicant for IMMUNODOT MONO-G 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 IMMUNODOT MONO-G TEST?

The FDA product code for IMMUNODOT MONO-G 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 TESTK974244IMMUNODOT MONO-M TESTK973939IMMUNOWELL VCA IGM TESTK973940IMMUNOWELL EBV VCA IGG 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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