Cleared Traditional

Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria

K220162 · Hycor Biomedical · Immunology
Feb 2022
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K220162 is an FDA 510(k) clearance for the Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Hycor Biomedical (Garden Grove, US). The FDA issued a Cleared decision on February 18, 2022, 29 days after receiving the submission on January 20, 2022. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K220162 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2022
Decision Date February 18, 2022
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHB — System, Test, Radioallergosorbent (rast) Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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