Cleared Traditional

K063160 - ALLERGEAZE PATCH TEST CHAMBERS
(FDA 510(k) Clearance)

K063160 · Smartpractice · General Hospital

Dec 2006

Decision

66d

Days

Class 1

Risk

K063160 is an FDA 510(k) clearance for the ALLERGEAZE PATCH TEST CHAMBERS. This device is classified as a Applicator, Absorbent Tipped, Non-sterile (Class I - General Controls, product code KXF).

Submitted by Smartpractice (Phoenix, US). The FDA issued a Cleared decision on December 22, 2006, 66 days after receiving the submission on October 17, 2006.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6025.

Submission Details

510(k) Number	K063160 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 17, 2006
Decision Date	December 22, 2006
Days to Decision	66 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement