510(k) Report

Devices descending from K042330

3 later devices reach Acetaminophen-SL Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081938Acetaminophen L3K Assay, and Acetaminophen L3K Assay, Models 506-10, 506-30Genzyme Diagnostics P.E.I., Inc.200922
+2K202644AcetaminophenSekisui Diagnostics P.E.I., Inc.20220—
+2K180835SEKURE Acetaminophen L3K AssaySekisui Diagnostics P.E.I., Inc.20190—