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 Reagent, Borrelia Serological Reagent
510(k) Number K082329
Device Name VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
Applicant
Viramed Biotech AG
1730 S. Ditmar St.
Oceanside,  CA  92054
Applicant Contact BARRY E MENEFEE
Correspondent
Viramed Biotech AG
1730 S. Ditmar St.
Oceanside,  CA  92054
Correspondent Contact BARRY E MENEFEE
Regulation Number866.3830
Classification Product Code
LSR  
Date Received08/14/2008
Decision Date 08/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-