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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Nameautomated antimicrobial susceptibility test system
Regulation Number866.1645
ApplicantABBOTT LABORATORIES
PMA NumberN50525
Supplement NumberS021
Date Received01/10/1989
Decision Date03/10/1989
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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