510(k) K991726— BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
Substantially EquivalentBinax, Inc.
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code GTZ
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, ME, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.