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 Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
510(k) Number K061239
Device Name EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
Applicant
Euroimmun Us, LLC
429 Rockaway Valley Rd.
Unit 1200
Boonton Township,  NJ  07005
Applicant Contact KATHRYN KOHL
Correspondent
Euroimmun Us, LLC
429 Rockaway Valley Rd.
Unit 1200
Boonton Township,  NJ  07005
Correspondent Contact KATHRYN KOHL
Regulation Number866.3305
Classification Product Code
MYF  
Subsequent Product Code
MXJ  
Date Received05/03/2006
Decision Date 06/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-