Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Automated Platelet Aggregation
510(k) Number K181777
Device Name AggreGuide A-100 ADP
Applicant
Aggredyne, Inc.
10530 Rockely Rd., Suite 150
Houston,  TX  77099
Applicant Contact Phillip Speros
Correspondent
Aggredyne, Inc.
10530 Rockely Rd., Suite 150
Houston,  TX  77099
Correspondent Contact Phillip Speros
Regulation Number864.5700
Classification Product Code
JOZ  
Date Received07/03/2018
Decision Date 03/29/2019
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-