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FDA 510(k) Application Details - K953643
Device Classification Name
Counter, Differential Cell
More FDA Info for this Device
510(K) Number
K953643
Device Name
Counter, Differential Cell
Applicant
TEXAS INTL. LABORATORIES, INC.
5 RAIN HOLLOW
HOUSTON, TX 77024 US
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Contact
YVES LEBIHAN
Other 510(k) Applications for this Contact
Regulation Number
864.5220
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Classification Product Code
GKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/1995
Decision Date
03/22/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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