FDA 510(k) Application Details - K060140

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K060140
Device Name	Calibrator, Secondary
Applicant	DIAGNOSTIC CHEMICALS LTD. 16 MCCARVILLE ST. CHARLOTTETOWN, PE C1E 2A6 CA Other 510(k) Applications for this Company
Contact	PENNY WHITE 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	01/19/2006
Decision Date	04/24/2006
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