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FDA 510(k) Application Details - K950568
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K950568
Device Name
Counter, Differential Cell
Applicant
ORTHO DIAGNOSTIC SYSTEMS, INC.
1001 U.S. HIGHWAY 202
P.O. BOX 350
RARITAN, NJ 08869-0606 US
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Contact
PATRICK A ROCHE
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Regulation Number
864.5220
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Classification Product Code
GKZ
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More FDA Info for this Product Code
Date Received
02/08/1995
Decision Date
05/13/1996
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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