FDA Product Code MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Leading manufacturers include Nelson Environmental Technologies, Inc. and Reprocessing Products Corporation (Rpc).
FDA 510(k) Cleared Strip, Test, Reagent, Residuals For Dialysate, Disinfectant Devices (Product Code MSY)
About Product Code MSY - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code MSY since 1997, with 13 receiving FDA clearance (average review time: 155 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under MSY have taken an average of 113 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.
MSY devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →