LeadCare II Blood Lead Analyzer (Extension of Suspension from the ARTG under paragraph 41GC of the Act)
Product name
LeadCare II Blood Lead Analyzer
ARTG
255472
Date action takes effect
Lapse date
Compliance action
Medical device suspension
Type of action
Extension of Suspension from the ARTG under paragraph 41GC of the Act
Grounds for regulatory action
Under subsection 41GA(1)(b); it is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).
Decision status
The sponsor has provided evidence of progress towards removing the grounds for cancelling the Device from the Register and the extension of the suspension from the ARTG will allow the completion of the actions necessary to remove these grounds. Suspension effective for additional 6 months.
Suspension effective for 6 months