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FDA 510(k)

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System

K-Number: K191398 · 2019-07-29

ApplicantZeus Scientific, Inc.
Decision Date2019-07-29
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System is a medical device manufactured by Zeus Scientific, Inc.. It received FDA 510(k) clearance on 2019-07-29 under approval number K191398. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System?

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Zeus Scientific, Inc.. The 510(k) number is K191398.

When was ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System approved by the FDA?

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System received FDA 510(k) clearance on 2019-07-29, under approval number K191398.

What company makes ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System?

ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System is manufactured by Zeus Scientific, Inc..

What is the FDA product code for ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System?

The FDA product code for ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System is LSR.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED

Other Devices by Zeus Scientific, Inc.

K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFine PMA P150045ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGG PMA P150042ASSAY,ENZYME LINKED IMMUNOSORBENT,PARVOVIRUS B19 IGM

Related Devices (Code: LSR)

K161513Anti-Borrelia burgdorferi US Westernblot (IgG)Euroimmun US K172722Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)Euroimmun Us, Inc. K172254Lyme B. burgdorferi (IgM) MarStripe TestTrinity Biotech K163713Sofia Lyme FIA, Sofia Lyme Control SetQuidel Corporation K163695Borrelia B31 ViraChip IgM Test KitViramed Biotech AG K163504Borrelia B31 ViraChip IgG Test KitViramed Biotech AG

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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