ESENSOR RESPIRATORY VIRAL PANEL— 510(k) K113731

Name: FDA 510(k) clearance K113731
Creator: U.S. Food and Drug Administration
Published: 2012-09-10

Substantially Equivalent

Clinical Micro Sensors, Inc.

FDA 510(k) clearance K113731 for ESENSOR RESPIRATORY VIRAL PANEL, Substantially Equivalent on 2012-09-10. Applicant: Clinical Micro Sensors, Inc.. Device class: 1.

Clearance details

Applicant: Clinical Micro Sensors, Inc.
Product code: Code JJH
Device class: Class 1
Regulation: 21 CFR 862.2310
Advisory panel: Clinical Chemistry
Date received: 2011-12-19
Decision date: 2012-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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