FDA 510(k) Application Details - K973050

Device Classification Name	Device, Automated Cell-Locating   More FDA Info for this Device
510(K) Number	K973050
Device Name	Device, Automated Cell-Locating
Applicant	TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD., #100 PALM BEACH GARDENS, FL 33410 US Other 510(k) Applications for this Company
Contact	R. OTTO STELLNER 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	08/15/1997
Decision Date	11/07/1997
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