PMA N50510S120
- Device
- VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S120
- Product code
- LTW
- Decision date
- 2000-02-01
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- The addition of the antibiotic cefpodoxime at concentrations fo 0.5, 1, 4mg/ml to the Vitek 2 Gram Negative Susceptibility Test System.
Current openFDA PMA Record#
- Device
- VITEK 2 GRAM NEGATIVE AST FOR CEFPODOXIME
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S120
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-02-01
- Decision code
- APPR
- Date received
- 1999-10-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- The addition of the antibiotic cefpodoxime at concentrations fo 0.5, 1, 4mg/ml to the Vitek 2 Gram Negative Susceptibility Test System.