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 Antigen, Iha, Cytomegalovirus
510(k) Number K974456
Device Name CMVGEN
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
Lexington,  MA  02173
Correspondent Contact CAROL MARBLE
Regulation Number866.3175
Classification Product Code
LJO  
Date Received11/25/1997
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-