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 Radioimmunoassay, Calcitonin
510(k) Number K182012
Device Name ADVIA Centaur Calcitonin (CALCT) assay
Applicant
Axis-Shield Diagnostics Limited
Luna Place, The Technology Park
Dundee,  GB DD2 1XA
Applicant Contact Claire Dora
Correspondent
Axis-Shield Diagnostics Limited
Luna Place, The Technology Park
Dundee,  GB DD2 1XA
Correspondent Contact Claire Dora
Regulation Number862.1140
Classification Product Code
JKR  
Date Received07/27/2018
Decision Date 12/21/2018
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
-
-