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FDA 510(k)

EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

K-Number: K894626 · 1989-10-16

ApplicantBion Ent., Ltd.
Decision Date1989-10-16
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Bion Ent., Ltd.. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K894626. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN?

EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K894626.

When did EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN receive FDA 510(k) clearance?

EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN received FDA 510(k) clearance on 1989-10-16, under 510(k) number K894626.

Who is the listed applicant for EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN?

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

What is the FDA product code for EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN?

The FDA product code for EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN is LLM.

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Other records listing Bion Ent., Ltd. 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.

K926066BION MUMPS-G ANTIBODY TEST SYSTEMK901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDEK894622VARICELLA ZOSTER VIRUSK894623RESPIRATORY SYNCYTIAL VIRUSK894624MUMPS VIRUSK891785BION EBV-G (VCA) TEST SYSTEM

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Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, 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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