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FDA 510(k)

BARTELS EPSTEIN-BARR VIRUS IGM EIA

K-Number: K922331 · 1992-09-02

ApplicantBaxter Diagnostics, Inc.
Decision Date1992-09-02
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BARTELS EPSTEIN-BARR VIRUS IGM EIA is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K922331. The device is classified under product code LJN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARTELS EPSTEIN-BARR VIRUS IGM EIA?

BARTELS EPSTEIN-BARR VIRUS IGM EIA is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Baxter Diagnostics, Inc.. The 510(k) number is K922331.

When did BARTELS EPSTEIN-BARR VIRUS IGM EIA receive FDA 510(k) clearance?

BARTELS EPSTEIN-BARR VIRUS IGM EIA received FDA 510(k) clearance on 1992-09-02, under 510(k) number K922331.

Who is the listed applicant for BARTELS EPSTEIN-BARR VIRUS IGM EIA?

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

What is the FDA product code for BARTELS EPSTEIN-BARR VIRUS IGM EIA?

The FDA product code for BARTELS EPSTEIN-BARR VIRUS IGM EIA is LJN.

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Other records listing Baxter Diagnostics, Inc. as applicant

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Related Devices (Code: LJN)

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K123021BIOPLEX 2200 EBV IGM KITBio-Rad LaboratoriesK073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600MFocus Diagnostics, Inc.K042092ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEMZeus Scientific, Inc.K033780MODIFICATION TO SERAQUEST VCA IGMQuest Intl., Inc.K990977SERAQUEST EB VAC IGMQuest Intl., Inc.K991459COPALIS EBV-M ANTIBODY ASSAYDiaSorin, 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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