PMA P000041S011

Device
CLEAREAD DETECT
Applicant
Riverain Medical Group
PMA number
P000041
Supplement
S011
Product code
MYN
Decision date
2012-02-27
Generic name
Analyzer, medical image
Approval order statement
APPROVAL TO MARKET THE DEVICE UNDER THE ADDITIONAL TRADE NAME CLEARREAD DETECT.

Current openFDA PMA Record#

Device
CLEAREAD DETECT
Applicant
Riverain Medical Group
PMA number
P000041
Supplement
S011
Product code
MYN
Generic name
Analyzer, medical image
Decision date
2012-02-27
Decision code
APPR
Date received
2012-02-14
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL TO MARKET THE DEVICE UNDER THE ADDITIONAL TRADE NAME CLEARREAD DETECT.