CLIA - Clinical Laboratory Improvement Amendments

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back To Search Results Test System Name Rapid Pathogen Screening RPS Adeno Detector   Document Number K052092 Analyte Name Adenovirus Analyte Specialty Virology Complexity WAIVED Effective Date 03/30/2006 Device Classification Name antigens, cf (including cf control), adenovirus 1-33 510(k) Number K052092 Device Name RPS ADENO DETECTOR Applicant RAPID PATHOGEN SCREENING 13946 wood duck circle bradenton,  FL  34202 Contact robert sambursky Regulation Number 866.3020 Classification Product Code GOD   Date Received 08/03/2005 Decision Date 11/22/2005 Decision substantially equivalent (SE) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Summary only summary summary Type Traditional Reviewed by Third Party No Expedited Review No