FDA 510(k) Application Details - K990554

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K990554
Device Name	Calibrator, Secondary
Applicant	DADE BEHRING, INC. P.O. BOX 6101 ROUTE 896, GLASGOW BLDG. 500 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	CATHY P CRAFT 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	02/22/1999
Decision Date	03/22/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review