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FDA 510(k), K091539, IQ 200 URINE ANALIZER BODY FLUIDS MODULE
FDA 510(k), K091539, IQ 200 URINE ANALIZER BODY FLUIDS MODULE
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510(K) Number: K091539
Device Name: IQ 200 URINE ANALIZER BODY FLUIDS MODULE
Manufacturer: WILLIAM M DOUGHERTY
Device Classification Name: Counter, Cell, Automated (Particle Counter)
Regulation Number: GKL
Classification Product Code: KXA
Date Received: 05/26/2009
Decision Date: 08/31/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: IQ 200 URINE ANALIZER BODY FLUIDS MODULE
Manufacturer: WILLIAM M DOUGHERTY
Device Classification Name: Counter, Cell, Automated (Particle Counter)
Regulation Number: GKL
Classification Product Code: KXA
Date Received: 05/26/2009
Decision Date: 08/31/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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