510(k) Report

Devices descending from K903152

2 later devices reach Emit Ethyl Alcohol Calibrators and Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032461Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc.200313
+2K181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation20180—