RPS ADENO DETECTOR PLUS


Device Classification Name

antigens, cf (including cf control), adenovirus 1-33

510(k) Number K110722
Device Name RPS ADENO DETECTOR PLUS
Applicant
RAPID PATHOGEN SCREENING, INC.
7227 delainey court
sarasota, 
FL 
34240

Applicant Contact douglas bueschel
Correspondent
RAPID PATHOGEN SCREENING, INC.
7227 delainey court
sarasota, 
FL 
34240

Correspodent Contact douglas bueschel
Regulation Number 866.3020
Classification Product Code
GOD  
Date Received 03/15/2011
Decision Date 05/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00921895
Reviewed by Third Party No

Combination Product

No