FDA 510(k) Application Details - K092570

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K092570
Device Name	Calibrator, Secondary
Applicant	HORIBA ABX SAS PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER 34184 FR Other 510(k) Applications for this Company
Contact	CAROLINE FERRER 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	08/21/2009
Decision Date	10/16/2009
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