510(k) Report

Devices descending from K852320

2 later devices reach Cobas FP Reagen for Procainamide & Pro Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.200312
+2K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific20090—