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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRAPIDSCREEN RS-2000D
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantRIVERAIN MEDICAL GROUP
3020 SOUTH TECH BLVD.
MIAMISBURG, OH 45342-4860
PMA NumberP000041
Supplement NumberS002
Date Received07/10/2003
Decision Date08/08/2003
Reclassified Date 02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SECOND DEVICE NAME OF "RAPIDSCREEN DIGITAL" (ABBREVIATED "RS-DIGITAL").
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