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 Campylobacter Spp.
510(k) Number K083464
Device Name PREMIER CAMPY, MODEL 618096
Applicant
Meridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Applicant Contact SUSAN D ROLIH
Correspondent
Meridian Bioscience, Inc.
3471 River Hills Dr.
Cincinnati,  OH  45244
Correspondent Contact SUSAN D ROLIH
Regulation Number866.3110
Classification Product Code
LQP  
Date Received11/24/2008
Decision Date 01/30/2009
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
-
-