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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact Douglas Bueschel
Regulation Number866.3020
Classification Product Code
GOD  
Date Received03/15/2011
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
Predetermined Change
Control Plan Authorized		 No
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