510(k) Report

Devices descending from K033840

11 later devices reach Cellavision DM96 Automatic Hematology Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171315Advanced RBC ApplicationCellaVision AB20170—
+1K092116Easycell Cell LocatorMedica Corp.20103—
+1K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB200942
+1K080595Cellavision DM96 with the Body Fluid ApplicationCellaVision AB20081—
+2K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB20201—
+2K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20202—
+2K171655cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc.201801
+2K102778Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB20110—
+3K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20250—
+3K221309AI100 with ShonitSigtuple Technologies Pvt., Ltd.20230—
+3K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20221—