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FDA 510(k)

AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST

K-Number: K911362 · 1991-10-07

ApplicantAmico Laboratories, Inc.
Decision Date1991-10-07
Product CodeLJN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Amico Laboratories, Inc.. It received FDA 510(k) clearance on 1991-10-07 under 510(k) number K911362. 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 AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST?

AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST is a medical device that received FDA 510(k) clearance on 1991-10-07. The listed applicant is Amico Laboratories, Inc.. The 510(k) number is K911362.

When did AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST receive FDA 510(k) clearance?

AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST received FDA 510(k) clearance on 1991-10-07, under 510(k) number K911362.

Who is the listed applicant for AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST?

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

What is the FDA product code for AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST?

The FDA product code for AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST 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.

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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