PMA N50510S108
- Device
- VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S108
- Product code
- LTW
- Decision date
- 2000-01-24
- Generic name
- Susceptibility test cards, antimicrobial
Current openFDA PMA Record#
- Device
- VITEK(R) 2 GRAM POSITIVE AST FOR HIGH-LEVEL GENTAMICIN
- Applicant
- Biomerieux Vitek, Inc.
- PMA number
- N50510
- Supplement
- S108
- Product code
- LTW
- Generic name
- Susceptibility test cards, antimicrobial
- Decision date
- 2000-01-24
- Decision code
- APPR
- Date received
- 1999-08-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename