• 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 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.
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Abbott Laboratories
100 abbott park road
dept 9va ap6c-2
abbott park, IL 60064-3500
PMA NumberN50525
Supplement NumberS024
Date Received08/23/1989
Decision Date09/25/1989
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No