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 record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS
Generic NameSusceptibility test cards, antimicrobial
Regulation Number866.1640
ApplicantBIOMERIEUX VITEK, INC.
595 ANGLUM DR.
HAZELWOOD, MO 63042-2395
PMA NumberN50510
Supplement NumberS032
Date Received05/20/1988
Decision Date08/10/1988
Reclassified Date 12/28/2001
Product Code LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
-
-