Cleared Traditional

NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

K182479 · Hycor Biomedical · Immunology
Dec 2018
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K182479 is an FDA 510(k) clearance for the NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus, 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 December 4, 2018, 85 days after receiving the submission on September 10, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K182479 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2018
Decision Date December 04, 2018
Days to Decision 85 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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