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 Activated Partial Thromboplastin
510(k) Number K253957
Device Name HemosIL Silica Clotting Time
Applicant
Instrumentation Laboratory (IL) Co.
180 Hartwell Rd.
Bedford,  MA  01730
Applicant Contact Kirivann Chhoeun
Correspondent
Instrumentation Laboratory (IL) Co.
180 Hartwell Rd.
Bedford,  MA  01730
Correspondent Contact Kirivann Chhoeun
Regulation Number864.7925
Classification Product Code
GFO  
Date Received12/10/2025
Decision Date 01/09/2026
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
-
-