FDA 510(k) Application Details - K023761

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K023761
Device Name	System, Automated Platelet Aggregation
Applicant	HELENA LABORATORIES 1530 LINDBERGH DR. P.O. BOX 752 BEAUMONT, TX 77704 US Other 510(k) Applications for this Company
Contact	PATRICIA FRANKS Other 510(k) Applications for this Contact
Regulation Number	864.5700   More FDA Info for this Regulation Number
Classification Product Code	JOZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2002
Decision Date	02/14/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review