FDA 510(k) Application Details - K032697

Device Classification Name	Calibrator, Primary   More FDA Info for this Device
510(K) Number	K032697
Device Name	Calibrator, Primary
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY P.O. BOX 6101, BUILDING 500 NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	LORRAINE H PIESTRAK Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2003
Decision Date	11/07/2003
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