510(k) Report

Devices descending from K971596

2 later devices reach Emit II Opiates 300/2000 Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013314OpiatesAbbott Laboratories20020—
+1K984232Modification of Emit D.a.U. Opiates AssaySyva Co.19990—