FDA 510(k) Application Details - K043070

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K043070
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	CANTERBURY 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	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2004
Decision Date	12/09/2004
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