FDA 510(k) Application Details - K083200

Device Classification Name	Calibrator For Cell Indices   More FDA Info for this Device
510(K) Number	K083200
Device Name	Calibrator For Cell Indices
Applicant	Streck 7002 SOUTH 109TH ST. OMAHA, NE 68128 US Other 510(k) Applications for this Company
Contact	ERIN JOHNSON Other 510(k) Applications for this Contact
Regulation Number	864.8150   More FDA Info for this Regulation Number
Classification Product Code	KRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/30/2008
Decision Date	02/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review