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 Instrument, Coagulation, Automated
510(k) Number K160276
Device Name ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
Applicant
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730 -2441
Applicant Contact NIKITA MALLADI
Correspondent
Instrumentation Laboratory CO
180 Hartwell Rd.
Bedford,  MA  01730 -2441
Correspondent Contact NIKITA MALLADI
Regulation Number864.5400
Classification Product Code
GKP  
Date Received02/02/2016
Decision Date 03/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-