FDA 510(k) Application Details - K033786

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K033786
Device Name	Calibrator, Secondary
Applicant	IBL GMBH 150 CHERRY LANE RD. EAST STROUDSBURG, PA 18301 US Other 510(k) Applications for this Company
Contact	Gary Lehnus 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	12/04/2003
Decision Date	02/27/2004
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