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 Acid, Folic, Radioimmunoassay
510(k) Number K972232
Device Name ABBOTT AXSYM FOLATE
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Applicant Contact LAURA L GRANITZ
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064 -3537
Correspondent Contact LAURA L GRANITZ
Regulation Number862.1295
Classification Product Code
CGN  
Date Received06/16/1997
Decision Date 06/24/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-