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 Kit, Test,Alpha-Fetoprotein For Testicular Cancer
510(k) Number K020806
Device Name ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
Applicant
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Applicant Contact THOMAS F FLYNN
Correspondent
BAYER CORP.
63 NORTH ST.
MEDFIELD,  MA  02052 -1688
Correspondent Contact THOMAS F FLYNN
Regulation Number866.6010
Classification Product Code
LOJ  
Date Received03/12/2002
Decision Date 03/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-