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FDA 510(k) Application Details - K070249
Device Classification Name
Cresolphthalein Complexone, Calcium
More FDA Info for this Device
510(K) Number
K070249
Device Name
Cresolphthalein Complexone, Calcium
Applicant
HORIBA ABX
PARC EUROMEDECINE
RUE DU CADUCEE
MONTPELLIER, HERAULT 34184 FR
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Contact
PASCAL MACZIOLA
Other 510(k) Applications for this Contact
Regulation Number
862.1145
More FDA Info for this Regulation Number
Classification Product Code
CIC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/26/2007
Decision Date
04/26/2007
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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