Cleared Traditional

Allergen-Specific IgE Assay 12 Allergen Bundle

K193613 · Hitachi Chemical Diagnostics, Inc. · Immunology
Oct 2021
Decision
662d
Days
Class 2
Risk

About This 510(k) Submission

K193613 is an FDA 510(k) clearance for the Allergen-Specific IgE Assay 12 Allergen Bundle, a System, Test, Radioallergosorbent (rast) Immunological (Class II — Special Controls, product code DHB), submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 18, 2021, 662 days after receiving the submission on December 26, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K193613 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2019
Decision Date October 18, 2021
Days to Decision 662 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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