• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name radioassay, vitamin b12
510(k) Number K121946
Device Name AXIS-SHIELD ACVTIVE-B12
Original Applicant
AXIS-SHIELD DIAGNOSTICS, LTD.
the technology park, luna place
dundee, scotland,  GB dd2 1xa
Original Contact simon john richards
Regulation Number862.1810
Classification Product Code
CDD  
Date Received07/03/2012
Decision Date 03/22/2013
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
-
-