510(k) Report

Devices descending from K003301

12 later devices reach Diffmaster Octavia Automatic Hematology Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033840Cellavision DM96 Automatic Hematology AnalyzerCellaVision AB2004111
+2K171315Advanced RBC ApplicationCellaVision AB20170—
+2K092116Easycell Cell LocatorMedica Corp.20103—
+2K092868Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127CellaVision AB200942
+2K080595Cellavision DM96 with the Body Fluid ApplicationCellaVision AB20081—
+3K200595CellaVision DC-1, CellaVision DC-1 PPACellaVision AB20201—
+3K201301X100 with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20202—
+3K171655cobas m 511 integrated hematology analyzerRoche Diagnostics Hematology, Inc.201801
+3K102778Cellavision DM1200 with the Body Fluid ApplictionCellaVision AB20110—
+4K243144X100/X100HT with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20250—
+4K221309AI100 with ShonitSigtuple Technologies Pvt., Ltd.20230—
+4K220013X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) ApplicationScopio Labs, Ltd.20221—