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FDA 510(k), K071562, D3 HEMATOLOGY ANALYZER, MODEL D3
FDA 510(k), K071562, D3 HEMATOLOGY ANALYZER, MODEL D3
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510(K) Number: K071562
Device Name: D3 HEMATOLOGY ANALYZER, MODEL D3
Manufacturer: ROGER BOURREE
Device Classification Name: Counter, Differential Cell
Regulation Number: GKZ
Classification Product Code: KXA
Date Received: 06/07/2007
Decision Date: 12/11/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
Device Name: D3 HEMATOLOGY ANALYZER, MODEL D3
Manufacturer: ROGER BOURREE
Device Classification Name: Counter, Differential Cell
Regulation Number: GKZ
Classification Product Code: KXA
Date Received: 06/07/2007
Decision Date: 12/11/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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