• 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.
 
DeviceVITEK 2 GRAM POSITIVE AST FOR BENZYLPENICILLIN
Classification Namesusceptibility test cards, antimicrobial
Generic Namesusceptibility test cards, antimicrobial
Regulation Number866.1640
Applicant
BIOMERIEUX VITEK, INC.
595 anglum dr.
hazelwood, MO 63042-2395
PMA NumberN50510
Supplement NumberS133
Date Received04/05/2000
Decision Date06/09/2000
Product Code
LTW[ Registered Establishments with LTW ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC BENZYLPENICILLIN AT CONCENTRATIONS OF 0.03, 0.06, 0.25 AND 0.5 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO BENZYLPENICILLIN IN THE RANGE OF <=0.06 TO >=2 MICROGRAMS/ML.
-
-