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FDA 510(k) Application Details - K060854
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K060854
Device Name
Calibrator, Secondary
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
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/29/2006
Decision Date
08/24/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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