FDA 510(k) Application Details - K011568

Device Classification Name	Calibrator, Primary   More FDA Info for this Device
510(K) Number	K011568
Device Name	Calibrator, Primary
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	P ARMSTRONG 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	05/21/2001
Decision Date	09/28/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review