Cleared Traditional

RPS ADENO DETECTOR

K052092 · Rapid Pathogen Screening · Microbiology

Nov 2005

Decision

112d

Days

Class 1

Risk

About This 510(k) Submission

K052092 is an FDA 510(k) clearance for the RPS ADENO DETECTOR, a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD), submitted by Rapid Pathogen Screening (Bradenton, US). The FDA issued a Cleared decision on November 22, 2005, 112 days after receiving the submission on August 2, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3020.

Submission Details

510(k) Number	K052092 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2005
Decision Date	November 22, 2005
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF