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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceSENSITITRE
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
210 business park dr.
sun prairie, WI 53590
PMA NumberN50531
Date Received07/19/1978
Decision Date05/04/1979
Reclassified Date 09/13/2002
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S003 S004 S005 S006 S007 
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