• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name immunoassay method, troponin subunit
510(k) Number K121214
Models 81600N, A98143;A98144
Device Name ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska,  MN  55318 1084
Original Contact kerrie oetter
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Codes
JIT   JJE  
Date Received04/23/2012
Decision Date 06/14/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-