FDA 510(k) Application Details - K013397

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K013397
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	FISHER DIAGNOSTICS 8365 VALLEY PIKE MIDDLETOWN, VA 22645-0307 US Other 510(k) Applications for this Company
Contact	JERALD P STEINER Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2001
Decision Date	02/15/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review