510(k) Report

Devices descending from K961370

2 later devices reach LA Positive Control Plasma through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020109Sigma Diagnostics Accuclot LA ControlSigma Diagnostics, Inc.20020—
+1K993332Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05Gradipore, Ltd.20000—