RPS ADENO DETECTOR PLUS

Antigens, Cf (including Cf Control), Adenovirus 1-33

RAPID PATHOGEN SCREENING, INC.

The following data is part of a premarket notification filed by Rapid Pathogen Screening, Inc. with the FDA for Rps Adeno Detector Plus.

Pre-market Notification Details

Device IDK110722
510k NumberK110722
Device Name:RPS ADENO DETECTOR PLUS
ClassificationAntigens, Cf (including Cf Control), Adenovirus 1-33
Applicant RAPID PATHOGEN SCREENING, INC. 7227 DELAINEY COURT Sarasota,  FL  34240
ContactDouglas Bueschel
CorrespondentDouglas Bueschel
RAPID PATHOGEN SCREENING, INC. 7227 DELAINEY COURT Sarasota,  FL  34240
Product CodeGOD  
CFR Regulation Number866.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-15
Decision Date2011-05-17
Summary:summary

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