BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522— 510(k) K982238
Substantially EquivalentBinax, Inc.
FDA 510(k) clearance K982238 for BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522, Substantially Equivalent on 1998-08-21. Applicant: Binax, Inc.. Device class: 2.
Clearance details
- Applicant
- Binax, Inc.
- Product code
- Code MJH
- Device class
- Class 2
- Regulation
- 21 CFR 866.3300
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, ME, US
Recent devices under product code MJH
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