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FDA 510(k)

ZEUS ELISA HSV GC-I IGG TEST SYSTEM

K-Number: K103363 · 2011-04-26

ApplicantZeus Scientific, Inc.
Decision Date2011-04-26
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ZEUS ELISA HSV GC-I IGG TEST SYSTEM 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 2011-04-26 under 510(k) number K103363. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEUS ELISA HSV GC-I IGG TEST SYSTEM?

ZEUS ELISA HSV GC-I IGG TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-26. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K103363.

When did ZEUS ELISA HSV GC-I IGG TEST SYSTEM receive FDA 510(k) clearance?

ZEUS ELISA HSV GC-I IGG TEST SYSTEM received FDA 510(k) clearance on 2011-04-26, under 510(k) number K103363.

Who is the listed applicant for ZEUS ELISA HSV GC-I IGG TEST SYSTEM?

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 ZEUS ELISA HSV GC-I IGG TEST SYSTEM?

The FDA product code for ZEUS ELISA HSV GC-I IGG TEST SYSTEM is MXJ.

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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: MXJ)

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.

K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.K220923Elecsys HSV-1 IgG (08948844160)Roche DiagnosticsK181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.K120625ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSVRoche DiagnosticsK120959BIOPLEX 2200 HSV-1 AND HSV-2 IGG KITBio-Rad Laboratories

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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