FDA 510(k) Application Details - K061667

Device Classification Name Counter, Differential Cell

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510(K) Number K061667
Device Name Counter, Differential Cell
Applicant ABBOTT LABORATORIES
5440 PATRICK HENRY DR.
SANTA CLARA, CA 95054 US
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Contact MICHELLE ROEDING
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Regulation Number 864.5220

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Classification Product Code GKZ
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Date Received 06/14/2006
Decision Date 07/10/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HE - Hematology
Review Advisory Committee HE - Hematology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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