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FDA 510(k)

EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY

K-Number: K931520 · 1994-04-26

ApplicantMrl Diagnostics
Decision Date1994-04-26
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Mrl Diagnostics. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K931520. 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 EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY?

EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Mrl Diagnostics. The 510(k) number is K931520.

When did EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY receive FDA 510(k) clearance?

EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY received FDA 510(k) clearance on 1994-04-26, under 510(k) number K931520.

Who is the listed applicant for EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY?

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

What is the FDA product code for EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY?

The FDA product code for EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY is LJN.

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Other records listing Mrl Diagnostics 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.

K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GK993754HSV-1 ELISA IGG, MODEL EL0910GK993724HSV-2 ELISA IGG, MODEL EL0920GK971007LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGM (WB0400M)K971006LYME DISEASE B. BURGDORFERI GENOGROUP 1 WESTERN BLOT IGG (WB0400G)K946353EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY

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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.

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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