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 Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K253817
Device Name IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La
Applicant
Immunodiagnostics Systems Limited
10 Didcot Way, Boldon Business Park
Boldon,  GB NE35 9PD
Applicant Contact Mohammed Adil Shaik Hussain
Correspondent
Immunodiagnostics Systems Limited
10 Didcot Way, Boldon Business Park
Boldon,  GB NE35 9PD
Correspondent Contact Mohammed Adil Shaik Hussain
Regulation Number866.5100
Classification Product Code
LLL  
Subsequent Product Codes
OBE   PET  
Date Received11/28/2025
Decision Date 08/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-