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 Kappa, Peroxidase, Antigen, Antiserum, Control
510(k) Number K924629
Device Name PAP ANTIBODY KIT
Applicant
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Applicant Contact STEPHEN A TILLSON
Correspondent
Ventana Medical Systems, Inc.
3865 N. Business Center Dr.
Tucson,  AZ  85705
Correspondent Contact STEPHEN A TILLSON
Regulation Number866.5550
Classification Product Code
DFD  
Date Received09/14/1992
Decision Date 02/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-