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FDA 510(k) Application Details - K060434
Device Classification Name
Bromcresol Green Dye-Binding, Albumin
More FDA Info for this Device
510(K) Number
K060434
Device Name
Bromcresol Green Dye-Binding, Albumin
Applicant
HORIBA ABX
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER, HERAULT 34184 FR
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Contact
TIM LAWTON
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Regulation Number
862.1035
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Classification Product Code
CIX
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More FDA Info for this Product Code
Date Received
02/21/2006
Decision Date
06/05/2007
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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