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

Premarket Approval (PMA)
  • 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
Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 EYE ST. NW STE. 625
WASHINGTON, DC 20006
PMA NumberP800030
Date Received06/03/1980
Decision Date02/18/1981
Reclassified Date 05/06/2003
Product Code LON 
Notice Date 03/17/1981
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S004 S005 S006 
-
-