510(k) Report

Devices descending from K943008

5 later devices reach Bioscan Reagent Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981555Diascreen Reagent StripsChronimed, Inc.199801
+1K971976Diascreen Reagent StripsDia-Screen Corp.19973—
+2K083184Tearlab Osmolarity SystemOcusense, Inc.20091—
+2K030650Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsUridynamics, Inc.20030—
+3K132066Inflamma DryRapid Pathogen Screening, Inc.201303