FDA 510(k) Application Details - K960827

Device Classification Name Counter, Differential Cell

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510(K) Number K960827
Device Name Counter, Differential Cell
Applicant BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS
7 LOVETON CIRCLE
SPARKS, MD 21152-0999 US
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Contact ROCKY GANSKE
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Regulation Number 864.5220

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Classification Product Code GKZ
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Date Received 02/29/1996
Decision Date 05/17/1996
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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