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FDA 510(k)

ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM

K-Number: K042092 · 2005-04-12

ApplicantZeus Scientific, Inc.
Decision Date2005-04-12
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2005-04-12 under 510(k) number K042092. 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 ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM?

ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-12. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K042092.

When did ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM receive FDA 510(k) clearance?

ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM received FDA 510(k) clearance on 2005-04-12, under 510(k) number K042092.

Who is the listed applicant for ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM?

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

What is the FDA product code for ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM?

The FDA product code for ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM is LJN.

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Other records listing Zeus Scientific, Inc. 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.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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