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FDA 510(k), K071652, HEMOCUE WBC SYSTEM
FDA 510(k), K071652, HEMOCUE WBC SYSTEM
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510(K) Number: K071652
Device Name: HEMOCUE WBC SYSTEM
Manufacturer: ALLAN WHITE
Device Classification Name: Counter, Cell, Automated (Particle Counter)
Regulation Number: GKL
Classification Product Code: KXA
Date Received: 06/18/2007
Decision Date: 10/25/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: HEMOCUE WBC SYSTEM
Manufacturer: ALLAN WHITE
Device Classification Name: Counter, Cell, Automated (Particle Counter)
Regulation Number: GKL
Classification Product Code: KXA
Date Received: 06/18/2007
Decision Date: 10/25/2007
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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