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 Filter, Blood, Dialysis
510(k) Number K253863
Device Name GUARDIAN™ Quick Dip Residual Chlorine (5212)
Applicant
Serim Research
3506 Reedy Dr.
Elkhart,  IN  46514
Applicant Contact Amy Sheets
Correspondent
Serim Research
3506 Reedy Dr.
Elkhart,  IN  46514
Correspondent Contact Amy Sheets
Regulation Number876.5820
Classification Product Code
FKJ  
Date Received12/03/2025
Decision Date 03/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-