FDA 510(k) Application Details - K020723

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K020723
Device Name	Calibrator, Secondary
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	RICHARD M VAUGHT 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	03/06/2002
Decision Date	05/08/2002
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