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FDA 510(k)

BIOPLEX 2200 EBV IGM KIT

K-Number: K123021 · 2012-11-02

ApplicantBio-Rad Laboratories
Decision Date2012-11-02
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOPLEX 2200 EBV IGM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2012-11-02 under 510(k) number K123021. 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 BIOPLEX 2200 EBV IGM KIT?

BIOPLEX 2200 EBV IGM KIT is a medical device that received FDA 510(k) clearance on 2012-11-02. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K123021.

When did BIOPLEX 2200 EBV IGM KIT receive FDA 510(k) clearance?

BIOPLEX 2200 EBV IGM KIT received FDA 510(k) clearance on 2012-11-02, under 510(k) number K123021.

Who is the listed applicant for BIOPLEX 2200 EBV IGM KIT?

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

What is the FDA product code for BIOPLEX 2200 EBV IGM KIT?

The FDA product code for BIOPLEX 2200 EBV IGM KIT is LJN.

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Related Devices (Code: LJN)

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.

K073381PLEXUS 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.K973939IMMUNOWELL VCA IGM TESTGenbio

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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