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FDA 510(k) Application Details - K982231
Device Classification Name
Counter, Differential Cell
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510(K) Number
K982231
Device Name
Counter, Differential Cell
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS, MN 55413 US
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Contact
KENNETH T EDDS
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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
06/25/1998
Decision Date
07/20/1998
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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