Search Results
Found 1 results
510(k) Data Aggregation
K Number
K171655Device Name
cobas m 511 integrated hematology analyzer
Manufacturer
Roche Diagnostics Hematology, Inc.
Date Cleared
2018-03-02
(270 days)
Product Code
GKZ, JOY
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
Roche Diagnostics Hematology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The cobas m 511 integrated hematology analyzer is a quantitative, automated analyzer with cell locating capability. It is intended for in vitro diagnostic use by a skilled operator in the clinical laboratory. The system prepares a stained microscope slide from EDTA-anticoagulated whole blood. It utilizes computer imaging to count the formed elements of blood and provide an image-based assessment of cell morphology, which may be reviewed by the operator, and also allows for manual classification of unclassified cells. The instrument reports the following parameters: RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, %NRBC, #NRBC, WBC, %NEUT, #NEUT, %LYMPH, #LYMPH, %MONO, #MONO, %EO, #EO, %BASO, #BASO, PLT, MPV, %RET, #RET, HGB-RET.
Device Description
The cobas m 511 system is a fully automated stand-alone hematology analyzer with integrated slide making capability and digital cell imaging. It provides a complete blood count, 5-part differential, and reticulocvte enumeration of samples of whole blood collected in K2 or K3 EDTA. It is designed for high throughput in the clinical laboratory environment.
Ask a Question
Page 1 of 1