PMA P870049S029
- Device
- MICROSCAN RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S029
- Product code
- LON
- Decision date
- 1999-06-24
- Classification
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Approval order statement
- Approval for the addition of a limitation to not report results for the testing of Escherichia coli and Klebsiella spp. with the antibiotic ticarcillin/K clavulanate in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.
Current openFDA PMA Record#
- Device
- MICROSCAN RAPID FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S029
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 1999-06-24
- Decision code
- APPR
- Date received
- 1999-06-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of a limitation to not report results for the testing of Escherichia coli and Klebsiella spp. with the antibiotic ticarcillin/K clavulanate in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.