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FDA 510(k) Application Details - K981950
Device Classification Name
Counter, Cell, Automated (Particle Counter)
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510(K) Number
K981950
Device Name
Counter, Cell, Automated (Particle Counter)
Applicant
SYSMEX CORP.
ONE WILDLIFE WAY
LONG GROVE, IL 60047-9596 US
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Contact
CATHERINE M TRESTER
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Regulation Number
864.5200
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Classification Product Code
GKL
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More FDA Info for this Product Code
Date Received
06/03/1998
Decision Date
11/03/1998
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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