PMA N50510S129
- Device
- VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S129
- Product code
- LTW
- Decision date
- 2000-04-26
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- The device, as modified, will be marketed under the trade name Vitek 2 Gram Negative Susceptibility Test Cards. Approval for the addition of the antibiotic imipenem at concentrations of 2, 4 and 16 micrograms/ml to the Vitek 2 Gram Negative Susceptibility Test System.
Current openFDA PMA Record#
- Device
- VITEK(R) 2 GRAM NEGATIVE AST FOR IMIPENEM
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S129
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-04-26
- Decision code
- APPR
- Date received
- 2000-03-09
- Supplement type
- Normal 180 Day Track
- Approval order statement
- The device, as modified, will be marketed under the trade name Vitek 2 Gram Negative Susceptibility Test Cards. Approval for the addition of the antibiotic imipenem at concentrations of 2, 4 and 16 micrograms/ml to the Vitek 2 Gram Negative Susceptibility Test System.