Cleared Traditional

Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae

K191510 · Hycor Biomedical · Immunology
Jul 2019
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K191510 is an FDA 510(k) clearance for the Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae, 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 July 31, 2019, 55 days after receiving the submission on June 6, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K191510 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2019
Decision Date July 31, 2019
Days to Decision 55 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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