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FDA 510(k) Application Details - K962633
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K962633
Device Name
Counter, Differential Cell
Applicant
ABX, INC.
RUE DU CADUCEE-BP7290
MONTPELLIER CEDEX 4 34184 FR
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Contact
BRICE PROUVE
Other 510(k) Applications for this Contact
Regulation Number
864.5220
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Classification Product Code
GKZ
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More FDA Info for this Product Code
Date Received
07/05/1996
Decision Date
11/04/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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