Cleared Traditional

K130524 - BREATHID HP SYSTEM
(FDA 510(k) Clearance)

K130524 · Exalenz Bioscience , Ltd. · Microbiology

May 2013

Decision

83d

Days

Class 1

Risk

K130524 is an FDA 510(k) clearance for the BREATHID HP SYSTEM. This device is classified as a Test, Urea (breath Or Blood) (Class I — General Controls, product code MSQ).

Submitted by Exalenz Bioscience , Ltd. (Wheat Ridge, US). The FDA issued a Cleared decision on May 22, 2013, 83 days after receiving the submission on February 28, 2013.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K130524 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2013
Decision Date	May 22, 2013
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF