AGGREGUIDE


Device Classification Name

system, automated platelet aggregation

510(k) Number K122162
Device Name AGGREGUIDE
Applicant
AGGREDYNE, INC.
11874 south evelyn circle
houston, 
TX 
77071

Applicant Contact j. harbey knauss
Correspondent
AGGREDYNE, INC.
11874 south evelyn circle
houston, 
TX 
77071

Correspodent Contact j. harbey knauss
Regulation Number 864.5700
Classification Product Code
JOZ  
Date Received 07/20/2012
Decision Date 12/20/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No