FDA 510(k) Application Details - K012103

Device Classification Name	Analyzer, Chromosome, Automated   More FDA Info for this Device
510(K) Number	K012103
Device Name	Analyzer, Chromosome, Automated
Applicant	APPLIED SPECTRAL IMAGING, LTD. 117 AHUZAH ST. RA'ANANNA 43373 IL Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	LNJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2001
Decision Date	09/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review