BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

FDA Premarket Approval P800030

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.

Pre-market Approval Supplement Details

DeviceBBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantBD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Date Received1980-06-03
Decision Date1981-02-18
Notice Date1981-03-17
PMAP800030
SupplementS
Product CodeLON 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 Eye St. Nw Ste. 625 washington, DC 20006

Supplemental Filings

Supplement NumberDateSupplement Type
P800030Original Filing
S006 1984-02-08
S005 1983-01-19
S004 1983-01-07
S003 1982-10-04
S002 1982-10-13
S001 1981-06-08

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