Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceSENSITITRE
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantTREK 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 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S003 S004 S005 S006 S007 
-
-