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 System, Blood Culturing
510(k) Number K974883
Device Name BACTEC MGIT 960 SYSTEM
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
Applicant Contact JODY J HOFFMANN
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
P.O. BOX 243
COCKEYSVILLE,  MD  21030 -0243
Correspondent Contact JODY J HOFFMANN
Regulation Number866.2560
Classification Product Code
MDB  
Date Received12/30/1997
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-