510(k) Report

Devices descending from K936131

2 later devices reach Cobas-FP Reagent for Phenytoin and Coba-FP Phenytoin Calibrators through their predicates, nearest generation first.

Generation	Number	Device	Applicant	Decided	Own descendants	Recalls
+1	K031856	Preciset TDM I and Preciset TDM II Calibrators	Roche Diagnostics Corp.	2003	1	2
+2	K091617	QMS Lidocaine Calibrators, Model 0374678	Thermo Fisher Scientific	2009	0	—