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 System, Test, Infectious Mononucleosis
510(k) Number K963425
Device Name GENZYME DIAGNOSTICS CONTRAST MONO
Applicant
Genzyme Diagnostics
1531 Industrial Rd.
San Carlos,  CA  94070
Applicant Contact DELIA R BETHELL, PH.D.
Correspondent
Genzyme Diagnostics
1531 Industrial Rd.
San Carlos,  CA  94070
Correspondent Contact DELIA R BETHELL, PH.D.
Regulation Number866.5640
Classification Product Code
KTN  
Date Received08/30/1996
Decision Date 02/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-