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 Epstein-Barr Virus, Other
510(k) Number K983839
Device Name BIOTEST ANTI-EBV RECOMBINANT
Applicant
Biotest Diagnostics Corp.
66 Ford Rd., Suite 131
Denville,  NJ  07834
Applicant Contact PATRICIA E BONNESS
Correspondent
Biotest Diagnostics Corp.
66 Ford Rd., Suite 131
Denville,  NJ  07834
Correspondent Contact PATRICIA E BONNESS
Regulation Number866.3235
Classification Product Code
LSE  
Date Received10/30/1998
Decision Date 06/09/1999
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
-
-