RPS ADENO DETECTOR PLUS— 510(k) K110722

Name: FDA 510(k) clearance K110722
Creator: U.S. Food and Drug Administration
Published: 2011-05-17

Substantially Equivalent

Rapid Pathogen Screening, Inc.

FDA 510(k) clearance K110722 for RPS ADENO DETECTOR PLUS, Substantially Equivalent on 2011-05-17. Applicant: Rapid Pathogen Screening, Inc.. Device class: 1.

Clearance details

Applicant: Rapid Pathogen Screening, Inc.
Product code: Code GOD
Device class: Class 1
Regulation: 21 CFR 866.3020
Advisory panel: Microbiology
Date received: 2011-03-15
Decision date: 2011-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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