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FDA 510(k)

BION EBV-G (VCA) TEST SYSTEM

K-Number: K891785 · 1989-08-31

ApplicantBion Ent., Ltd.
Decision Date1989-08-31
Product CodeJRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BION EBV-G (VCA) TEST SYSTEM 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 1989-08-31 under 510(k) number K891785. The device is classified under product code JRY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BION EBV-G (VCA) TEST SYSTEM?

BION EBV-G (VCA) TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1989-08-31. The listed applicant is Bion Ent., Ltd.. The 510(k) number is K891785.

When did BION EBV-G (VCA) TEST SYSTEM receive FDA 510(k) clearance?

BION EBV-G (VCA) TEST SYSTEM received FDA 510(k) clearance on 1989-08-31, under 510(k) number K891785.

Who is the listed applicant for BION EBV-G (VCA) TEST SYSTEM?

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 BION EBV-G (VCA) TEST SYSTEM?

The FDA product code for BION EBV-G (VCA) TEST SYSTEM is JRY.

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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 VIRUSK894626EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN

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Related Devices (Code: JRY)

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.

K042118ATHENA MULTI-LYTE EBV IGG TEST SYSTEMZeus Scientific, Inc.K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.Stellar Bio Systems, Inc.K884829EBV EARLY ANTIGEN (R+D)Hillcrest BiologicalsK822734EBV IGM TESTGull Laboratories, Inc.K822985EBV-M KITLitton BioneticsK821849EBV-VCA ANTIBODY ASSAY KITBiotech Research Laboratories, 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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