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 cardiac c-reactive protein, antigen, antiserum, and control
510(k) Number K233242
Device Name Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Applicant
Siemens HealthCare Diagnostics Inc.
500 GBC Drive
Newark,  DE  19714
Applicant Contact Anthony Calabro
Correspondent
Siemens HealthCare Diagnostics Inc.
500 GBC Drive
Newark,  DE  19714
Correspondent Contact Anthony Calabro
Regulation Number866.5270
Classification Product Code
NQD  
Subsequent Product Code
JIX  
Date Received09/28/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-