ZEUS IFA(TM) nDNA Test System, ZEUS dIFine— 510(k) K231616

Name: FDA 510(k) clearance K231616
Creator: U.S. Food and Drug Administration
Published: 2023-08-31

Substantially Equivalent

Zeus Scientific

FDA 510(k) clearance K231616 for ZEUS IFA(TM) nDNA Test System, ZEUS dIFine, Substantially Equivalent on 2023-08-31. Applicant: Zeus Scientific. Device class: 2.

Clearance details

Applicant: Zeus Scientific
Product code: Code KTL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2023-06-02
Decision date: 2023-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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