510(k) Report

Devices descending from K940043

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971976Diascreen Reagent StripsDia-Screen Corp.19973—
+1K961375Dia Screen 10 Way Reagent StripsGenesis Labs, Inc.19965—
+2K083184Tearlab Osmolarity SystemOcusense, Inc.20091—
+2K030650Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsUridynamics, Inc.20030—
+2K981555Diascreen Reagent StripsChronimed, Inc.199801
+3K132066Inflamma DryRapid Pathogen Screening, Inc.201303