Cleared Dual Track

Kenota 1 Total IgE; Kenota 1 (instrument)

K231151 · Kenota, Inc. · Immunology
May 2024
Decision
403d
Days
Class 2
Risk

About This 510(k) Submission

K231151 is an FDA 510(k) clearance for the Kenota 1 Total IgE; Kenota 1 (instrument), a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Kenota, Inc. (Kitchener, CA). The FDA issued a Cleared decision on May 31, 2024, 403 days after receiving the submission on April 24, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K231151 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2023
Decision Date May 31, 2024
Days to Decision 403 days
Submission Type Dual Track
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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