FDA 510(k) Application Details - K052101

Device Classification Name	Calibrator For Hemoglobin And Hematocrit Measurement   More FDA Info for this Device
510(K) Number	K052101
Device Name	Calibrator For Hemoglobin And Hematocrit Measurement
Applicant	Roche Diagnostics 9115 HAGUE ROAD INDIANAPOLIS, IN 46250-0416 US Other 510(k) Applications for this Company
Contact	THERESA M AMBROSE Other 510(k) Applications for this Contact
Regulation Number	864.8165   More FDA Info for this Regulation Number
Classification Product Code	KRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2005
Decision Date	08/26/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review