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FDA 510(k) Application Details - K123171
Device Classification Name
Azo Dye, Calcium
More FDA Info for this Device
510(K) Number
K123171
Device Name
Azo Dye, Calcium
Applicant
HORIBA ABX S.A.S.
PARC EUROMEDECINE
RUE DU CADUCEE-BP 7290
MONTPELLIER CEDEX 4, HERAULT 34184 FR
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Contact
CAROLINE FERRER
Other 510(k) Applications for this Contact
Regulation Number
862.1145
More FDA Info for this Regulation Number
Classification Product Code
CJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/09/2012
Decision Date
07/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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