510(k) Report

Devices descending from K935254

2 later devices reach Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102552Hemosil LA Positive ControlInstrumentation Laboratory CO20110—
+1K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc.20100—