PMA N50510S116
- Device
- VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S116
- Product code
- LTW
- Decision date
- 2000-02-08
- Classification
- Susceptibility Test Cards, Antimicrobial
- Generic name
- Susceptibility test cards, antimicrobial
- Approval order statement
- The addition of the antibiotic nitrofurantoin at concentration fo 16,32 and 64 mg/ml to the Vitek 2 Gram Positive Susceptibility Test System.
Current openFDA PMA Record#
- Device
- VITEK(R) GRAM POSITIVE AST FOR NITROFURANTOIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S116
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-02-08
- Decision code
- APPR
- Date received
- 1999-09-15
- Supplement type
- Normal 180 Day Track
- Approval order statement
- The addition of the antibiotic nitrofurantoin at concentration fo 16,32 and 64 mg/ml to the Vitek 2 Gram Positive Susceptibility Test System.