Cleared Traditional

ESENSOR RESPIRATORY VIRAL PANEL

K113731 · Clinical Micro Sensors, Inc. · Microbiology
Sep 2012
Decision
266d
Days
Class 1
Risk

About This 510(k) Submission

K113731 is an FDA 510(k) clearance for the ESENSOR RESPIRATORY VIRAL PANEL, a Clinical Sample Concentrator (Class I — General Controls, product code JJH), submitted by Clinical Micro Sensors, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 10, 2012, 266 days after receiving the submission on December 19, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2310.

Submission Details

510(k) Number K113731 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2011
Decision Date September 10, 2012
Days to Decision 266 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JJH — Clinical Sample Concentrator
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2310