510(k) Report

Devices descending from K923783

3 later devices reach Ethyl Alcohol Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032461Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221Lin-Zhi International, Inc.200313
+1K971506Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol CalibratorBeckman Instruments, Inc.19970—
+2K181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis Corporation20180—