Cleared Traditional

RPS ADENO DETECTOR PLUS

K110722 · Rapid Pathogen Screening, Inc. · Microbiology
May 2011
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K110722 is an FDA 510(k) clearance for the RPS ADENO DETECTOR PLUS, a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD), submitted by Rapid Pathogen Screening, Inc. (Sarasota, US). The FDA issued a Cleared decision on May 17, 2011, 63 days after receiving the submission on March 15, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number K110722 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2011
Decision Date May 17, 2011
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GOD — Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3020

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