PMA P870049S024
- Device
- MICROSCAN RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S024
- Product code
- LON
- Decision date
- 1996-03-12
- Classification
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Approval order statement
- APPROVAL FOR OFLOXACIN TO BE ADDED TOTHE GRAM-NEGATIVE RAPID FLUOROGENIC PANELS AT THE EQUIVALENCY CONCENTRATIONS OF 0.25 UG/ML TO 16 UG/ML
Current openFDA PMA Record#
- Device
- MICROSCAN RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S024
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 1996-03-12
- Decision code
- APPR
- Date received
- 1995-08-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR OFLOXACIN TO BE ADDED TOTHE GRAM-NEGATIVE RAPID FLUOROGENIC PANELS AT THE EQUIVALENCY CONCENTRATIONS OF 0.25 UG/ML TO 16 UG/ML