FDA 510(k) Application Details - K011337

Device Classification Name	System, Automated Platelet Aggregation   More FDA Info for this Device
510(K) Number	K011337
Device Name	System, Automated Platelet Aggregation
Applicant	ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	RHONDA MOE 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	05/02/2001
Decision Date	10/16/2001
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