510(k) Report

Devices descending from K952623

3 later devices reach Cryo Check Lupus Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061803Sta - Control LA 1+2Diagnostica Stago, Inc.20061—
+1K032804Cryocheck Weak Lupus Positive ControlPrecision Biologic20030—
+2K142132Pool NormDiagnostics Stago S.A.S.20140—