Cleared Traditional

AP3600 Automated Instrument

K182793 · Hitachi Chemical Diagnostics, Inc. · Immunology
Mar 2019
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K182793 is an FDA 510(k) clearance for the AP3600 Automated Instrument, 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 March 19, 2019, 169 days after receiving the submission on October 1, 2018. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K182793 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2018
Decision Date March 19, 2019
Days to Decision 169 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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