PMA P870049
- Device
- MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S032
- Product code
- LON
- Decision date
- 2001-11-30
- Classification
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE RAPID GRAM POSITIVE PROCEDURAL MANUALS FOR INTERPRETIVE CRITERIA FOR PENICILLIN AND AMPICILLIN WHEN TESTING STREPTOCOCCUS SPECIES OTHER THAN STREPTOCOCCUS PNEUMONIA.
Current openFDA PMA Record#
- Device
- MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS
- Applicant
- Dade Intl., Inc.
- PMA number
- P870049
- Supplement
- S032
- Product code
- LON
- Generic name
- SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
- Decision date
- 2001-11-30
- Decision code
- APPR
- Date received
- 2001-11-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE RAPID GRAM POSITIVE PROCEDURAL MANUALS FOR INTERPRETIVE CRITERIA FOR PENICILLIN AND AMPICILLIN WHEN TESTING STREPTOCOCCUS SPECIES OTHER THAN STREPTOCOCCUS PNEUMONIA.