• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceCLEAREAD DETECT
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
RIVERAIN MEDICAL GROUP
3020 south tech blvd.
miamisburg, OH 45342-4860
PMA NumberP000041
Supplement NumberS011
Date Received02/14/2012
Decision Date02/27/2012
Product Code
MYN[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL TO MARKET THE DEVICE UNDER THE ADDITIONAL TRADE NAME CLEARREAD DETECT.
-
-