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 immunoassay method, troponin subunit
510(k) Number K974103
Device Name ABBOTT AXSYM TROPONIN-I
Applicant
ABBOTT LABORATORIES
100/200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact LAURA L GRANITZ
Correspondent
ABBOTT LABORATORIES
100/200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact LAURA L GRANITZ
Regulation Number862.1215
Classification Product Code
MMI  
Date Received10/31/1997
Decision Date 11/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-