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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1875 eye st. nw ste. 625
washington, DC 20006
PMA NumberP800030
Supplement NumberS001
Date Received06/08/1981
Decision Date08/26/1981
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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