Home / 510(k) Clearances / K041074

510(k) K041074

BD FACSCANTO WITH BD FACSANTO SOFTWARE by Bd Biosciences — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2004
Date Received
April 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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