PMA N50510S128
- Device
- VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S128
- Product code
- LTW
- Decision date
- 2000-04-17
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- Approval for the addition of the antibiotic ticarcillin/clavulanic acid at concentrations of 8/2, 32/2, 64/2 ug/ml ot the Vitek 2 Gram Negative Susceptibility Test System.
Current openFDA PMA Record#
- Device
- VITEK(R) 2 GRAM NEGATIVE AST FOR TICARCILLIN/CLAVULANIC ACID
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S128
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-04-17
- Decision code
- APPR
- Date received
- 2000-03-09
- Supplement type
- Normal 180 Day Track
- Approval order statement
- Approval for the addition of the antibiotic ticarcillin/clavulanic acid at concentrations of 8/2, 32/2, 64/2 ug/ml ot the Vitek 2 Gram Negative Susceptibility Test System.