510(k) Report

Devices descending from K062077

1 later device reach Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143500Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine…Immunalysis Corporation20150—