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510(k) Data Aggregation
K Number
K014203Device Name
ABX MICROS 60 HEMATOLOGY ANALYZER
Manufacturer
ABX DIAGNOSTICS
Date Cleared
2002-02-28
(69 days)
Product Code
GKX, GKZ
Regulation Number
864.5200Why did this record match?
Product Code :
GKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
Device Description
The ABX MICROS 60 Hematology Analyzer is a bench top clinical laboratory instrument which analyzes in vitro samples of whole blood to provide complete blood count data using principles of cytochemistry, focused flow impedance, and light transmission technology. The system is equipped with automatic calibration; Automated smart cards based for: calibration, QC with 93 multiple range files and memory with 60 erasable results.
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