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 Manual Antimicrobial Susceptibility Test Systems
510(k) Number K951539
Device Name ENTEROCOCCUS SCREENING MEDIUM
Applicant
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030 -0243
Applicant Contact JUDITH J SMITH
Correspondent
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030 -0243
Correspondent Contact JUDITH J SMITH
Regulation Number866.1640
Classification Product Code
JWY  
Date Received04/03/1995
Decision Date 06/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-