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. |
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Device | CLEAREAD DETECT |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | RIVERAIN MEDICAL GROUP 3020 SOUTH TECH BLVD. MIAMISBURG, OH 45342-4860 |
PMA Number | P000041 |
Supplement Number | S011 |
Date Received | 02/14/2012 |
Decision Date | 02/27/2012 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MARKET THE DEVICE UNDER THE ADDITIONAL TRADE NAME CLEARREAD DETECT. |
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