Cleared Special

Quantia IgE

K214068 · Biokit, S.A. · Immunology
Feb 2023
Decision
421d
Days
Class 2
Risk

About This 510(k) Submission

K214068 is an FDA 510(k) clearance for the Quantia IgE, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Biokit, S.A. (Lli?? D?Amunt, ES). The FDA issued a Cleared decision on February 21, 2023, 421 days after receiving the submission on December 27, 2021. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K214068 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2021
Decision Date February 21, 2023
Days to Decision 421 days
Submission Type Special
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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