• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameAMMENDMENT TO E. COLI ASC
Classification Namesusceptibility test cards, antimicrobial
Generic Nameproteus antimicrobial susceptability card
Regulation Number866.1640
ApplicantVITEK SYSTEMS, INC.
PMA NumberN50510
Supplement NumberS005
Date Received03/28/1980
Decision Date06/16/1980
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
-
-