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 Test, Cystatin C
510(k) Number K181082
Device Name ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
Applicant
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  NJ  19714
Applicant Contact Kathleen Dray-Lyons
Correspondent
Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr.
Newark,  NJ  19714
Correspondent Contact Kathleen Dray-Lyons
Regulation Number862.1225
Classification Product Code
NDY  
Date Received04/24/2018
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-