- Device
- MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S025
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 1996-05-03
- Decision code
- APPR
- Date received
- 1995-09-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR EXPANDED GENTAMICIN DILUTIONS AT CONCENTRATIONS OF 0.12-4, 6, AND 8UG/ML, THE REMOVAL OF THE LIMITATION FOR THE TESTING OF SALMONELLA/SHIGELLA WITH GENTAMICIN, AND ADDITIONAL LIMITATIONS FOR THE TESTING OF ACINETOBACTER BAUMANII AND STENOTROPHOMONAS MALTOPHILIA WITH GENTAMICIN