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FDA 510(k)

IMMUNOWELL EA (D) IGG TEST

K-Number: K010301 · 2001-06-11

ApplicantGenbio
Decision Date2001-06-11
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOWELL EA (D) 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 2001-06-11 under 510(k) number K010301. 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 EA (D) IGG TEST?

IMMUNOWELL EA (D) IGG TEST is a medical device that received FDA 510(k) clearance on 2001-06-11. The listed applicant is Genbio. The 510(k) number is K010301.

When did IMMUNOWELL EA (D) IGG TEST receive FDA 510(k) clearance?

IMMUNOWELL EA (D) IGG TEST received FDA 510(k) clearance on 2001-06-11, under 510(k) number K010301.

Who is the listed applicant for IMMUNOWELL EA (D) 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 EA (D) IGG TEST?

The FDA product code for IMMUNOWELL EA (D) 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.

K974226IMMUNODOT MONO-G TESTK974244IMMUNODOT MONO-M TESTK973941IMMUNOWELL EBNA IGG TESTK973939IMMUNOWELL VCA IGM TESTK973940IMMUNOWELL EBV VCA 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.K062211BIOPLEX 2200 EBV IGG PANEL FOR 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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