FDA 510(k) Application Details - K043378

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K043378
Device Name	Calibrator, Secondary
Applicant	DREW SCIENTIFIC LTD. SOWERBY WOODS BUSINESS PARK PARK ROAD BARROW IN FURNESS CUMBRIA LA14 4QR GB Other 510(k) Applications for this Company
Contact	DIANE HILL 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	12/08/2004
Decision Date	12/29/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review