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FDA 510(k) Application Details - K050721
Device Classification Name
Mixture, Hematology Quality Control
More FDA Info for this Device
510(K) Number
K050721
Device Name
Mixture, Hematology Quality Control
Applicant
HORIBA ABX
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER, HERAULT 34184 FR
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Contact
TIM LAWTON
Other 510(k) Applications for this Contact
Regulation Number
864.8625
More FDA Info for this Regulation Number
Classification Product Code
JPK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2005
Decision Date
06/01/2005
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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