Cleared Traditional

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

K130524 · Exalenz Bioscience , Ltd. · Microbiology device
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 Substantially Equivalent - Traditional 510(k) (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

Device Classification

Product Code MSQ - Test, Urea (breath Or Blood)
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.3110