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FDA 510(k)

EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI

K-Number: K811262 · 1981-05-27

ApplicantZeus Scientific, Inc.
Decision Date1981-05-27
Product CodeJRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811262. 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 EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI?

EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K811262.

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

EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811262.

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

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

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

The FDA product code for EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI is JRY.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.K891785BION EBV-G (VCA) TEST SYSTEMBion Ent., Ltd.K884829EBV EARLY ANTIGEN (R+D)Hillcrest BiologicalsK822734EBV IGM TESTGull Laboratories, Inc.K822985EBV-M KITLitton Bionetics

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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