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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
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
1875 Eye St. NW Suite 625
Washington, DC 20006
PMA NumberP800030
Supplement NumberS005
Date Received01/19/1983
Decision Date06/03/1983
Reclassified Date05/06/2003
Product Code LON 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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