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FDA 510(k)

COPALIS EBV-M ANTIBODY ASSAY

K-Number: K991459 · 1999-05-14

ApplicantDiaSorin, Inc.
Decision Date1999-05-14
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPALIS EBV-M ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 1999-05-14 under 510(k) number K991459. 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 COPALIS EBV-M ANTIBODY ASSAY?

COPALIS EBV-M ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1999-05-14. The listed applicant is DiaSorin, Inc.. The 510(k) number is K991459.

When did COPALIS EBV-M ANTIBODY ASSAY receive FDA 510(k) clearance?

COPALIS EBV-M ANTIBODY ASSAY received FDA 510(k) clearance on 1999-05-14, under 510(k) number K991459.

Who is the listed applicant for COPALIS EBV-M ANTIBODY ASSAY?

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

What is the FDA product code for COPALIS EBV-M ANTIBODY ASSAY?

The FDA product code for COPALIS EBV-M ANTIBODY ASSAY is LJN.

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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.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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