PMA N50510S114
- Device
- VITEK 2 GRAM NEGATIVE NORFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S114
- Product code
- LTW
- Decision date
- 2000-02-07
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- The addition of the antibiotic norfloxacin at concentrations of 1, 8, and 32ug/ml to the Vitek 2 gram Negative Susceptibility Test System.
Current openFDA PMA Record#
- Device
- VITEK 2 GRAM NEGATIVE NORFLOXACIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S114
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-02-07
- Decision code
- APPR
- Date received
- 1999-09-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- The addition of the antibiotic norfloxacin at concentrations of 1, 8, and 32ug/ml to the Vitek 2 gram Negative Susceptibility Test System.