FDA 510(k) Application Details - K963493

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K963493
Device Name	Calibrator, Secondary
Applicant	DADE CHEMISTRY SYSTEMS, INC. P.O. BOX 6101, GLASGOW GLDG. 500 MAILBOX 514 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	09/03/1996
Decision Date	12/03/1996
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