Cleared Traditional

K112910 - AP 72OS SEMI-AUTOMATED INSTRUMENT (FDA 510(k) Clearance)

K112910 · Hitachi Chemical Diagnostics, Inc. · Immunology device
Dec 2012
Decision
444d
Days
Class 2
Risk

K112910 is an FDA 510(k) clearance for the AP 72OS SEMI-AUTOMATED INSTRUMENT. This device is classified as 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 December 20, 2012, 444 days after receiving the submission on October 3, 2011.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K112910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date December 20, 2012
Days to Decision 444 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