FDA 510(k) Application Details - K980375

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K980375
Device Name	Device, Automated Cell-Locating
Applicant	APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B SANTA CLARA, CA 95051 US Other 510(k) Applications for this Company
Contact	PATRICIA A MILBANK Other 510(k) Applications for this Contact
Regulation Number	864.5260   More FDA Info for this Regulation Number
Classification Product Code	JOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/30/1998
Decision Date	06/09/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review