Cleared Traditional

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

K231616 · Zeus Scientific · Immunology
Aug 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231616 is an FDA 510(k) clearance for the ZEUS IFA(TM) nDNA Test System, ZEUS dIFine, a Anti-dna Indirect Immunofluorescent Solid Phase (Class II — Special Controls, product code KTL), submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on August 31, 2023, 90 days after receiving the submission on June 2, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K231616 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2023
Decision Date August 31, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code KTL — Anti-dna Indirect Immunofluorescent Solid Phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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