FDA 510(k) Application Details - K053031

Device Classification Name	Control, Hemoglobin, Abnormal   More FDA Info for this Device
510(K) Number	K053031
Device Name	Control, Hemoglobin, Abnormal
Applicant	CANTEBURY SCIENTIFIC LTD. 14 POPE STREET CHRISTCHURCH, CANTERBURY 8001 NZ Other 510(k) Applications for this Company
Contact	MAURICE OWEN Other 510(k) Applications for this Contact
Regulation Number	864.7415   More FDA Info for this Regulation Number
Classification Product Code	JCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/2005
Decision Date	12/07/2005
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