510(k) Report

Devices descending from K902577

3 later devices reach Emit (R) II Opiate Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971596Emit II Opiates 300/2000 AssayBehring Diagnostics, Inc.19972—
+2K013314OpiatesAbbott Laboratories20020—
+2K984232Modification of Emit D.a.U. Opiates AssaySyva Co.19990—