510(k) Report

Devices descending from K001256

6 later devices reach Control Plasma N through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed20050—
+1K023309Control Plasma NDade Behring, Inc.20022—
+1K013708Reference Check, Catalog Number-RCN-10Precision Biologic20011—
+2K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaAffinity Biologicals, Inc.20090—
+2K042333Control Plasma N, Proc Control PlasmaDade Behring, Inc.20040—
+2K042209Control Plasma N and Control Plasma PDade Behring, Inc.20040—