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FDA 510(k)

EBV VCA IGM ANTIBODY ASSAY KIT

K-Number: K864604 · 1987-02-02

ApplicantGranbio, Inc.
Decision Date1987-02-02
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EBV VCA IGM ANTIBODY ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Granbio, Inc.. It received FDA 510(k) clearance on 1987-02-02 under 510(k) number K864604. 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 EBV VCA IGM ANTIBODY ASSAY KIT?

EBV VCA IGM ANTIBODY ASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-02-02. The listed applicant is Granbio, Inc.. The 510(k) number is K864604.

When did EBV VCA IGM ANTIBODY ASSAY KIT receive FDA 510(k) clearance?

EBV VCA IGM ANTIBODY ASSAY KIT received FDA 510(k) clearance on 1987-02-02, under 510(k) number K864604.

Who is the listed applicant for EBV VCA IGM ANTIBODY ASSAY KIT?

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

What is the FDA product code for EBV VCA IGM ANTIBODY ASSAY KIT?

The FDA product code for EBV VCA IGM ANTIBODY ASSAY KIT is LJN.

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Other records listing Granbio, 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.

K951822EBNA ENZYME IMMUNOASSAY KITK934774UNKNOWNK901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMK901840(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUMK881617INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAYK871298EBNA ACIF ASSAY KIT

View all 8 devices →

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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