PMA N50510S115
- Device
- VITEK 2 GRAM NEGATIVE TETRACYCLINE
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S115
- Product code
- LTW
- Decision date
- 2000-02-08
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- Additioin of the antibiotic tetracycline at concentrations of 2,4,and 8mg/ml to the Vitek 2 Gram Negative Susceptibility Test System
Current openFDA PMA Record#
- Device
- VITEK 2 GRAM NEGATIVE TETRACYCLINE
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S115
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-02-08
- Decision code
- APPR
- Date received
- 1999-09-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Additioin of the antibiotic tetracycline at concentrations of 2,4,and 8mg/ml to the Vitek 2 Gram Negative Susceptibility Test System