FDA 510(k) Application Details - K950342

Device Classification Name Counter, Differential Cell

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510(K) Number K950342
Device Name Counter, Differential Cell
Applicant BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
2350 QUME DR.
SAN JOSE, CA 95131-1807 US
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Contact ANNA M LONGWELL
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Regulation Number 864.5220

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Classification Product Code GKZ
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Date Received 01/27/1995
Decision Date 02/20/1996
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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