ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System— 510(k) K190907

Name: FDA 510(k) clearance K190907
Creator: U.S. Food and Drug Administration
Published: 2019-07-29

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K190907 for ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System, Substantially Equivalent on 2019-07-29. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2019-04-08
Decision date: 2019-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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