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FDA 510(k) Application Details - K080887
Device Classification Name
Counter, Urine Particle
More FDA Info for this Device
510(K) Number
K080887
Device Name
Counter, Urine Particle
Applicant
SYSMEX AMERICA, INC.
ONE NELSON C. WHITE PARKWAY
MUNDELEIN, IL 60060 US
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Contact
NINA GAMPERLING
Other 510(k) Applications for this Contact
Regulation Number
864.5200
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Classification Product Code
LKM
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More FDA Info for this Product Code
Date Received
03/31/2008
Decision Date
05/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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