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 Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
510(k) Number K151046
Device Name illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
Applicant
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Dr
CINCINNATI,  OH  45244
Applicant Contact STEFANIE JOHNS
Correspondent
MERIDIAN BIOSCIENCE, INC.
3471 River Hills Dr
CINCINNATI,  OH  45244
Correspondent Contact STEFANIE JOHNS
Regulation Number866.3309
Classification Product Code
PGI  
Date Received04/20/2015
Decision Date 07/17/2015
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
-
-