MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST— 510(k) K010523
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K010523 for MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST, Substantially Equivalent on 2001-03-15. Applicant: Binax, Inc.. Device class: 1.
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code GTZ
- Device class
- Class 1
- Regulation
- 21 CFR 866.3740
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portland, ME, US
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More clearances from Binax, Inc.
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