MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012— 510(k) K070522
Substantially EquivalentInverness Medical Professional Diagnostics
FDA 510(k) clearance K070522 for MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012, Substantially Equivalent on 2007-03-15. Applicant: Inverness Medical Professional Diagnostics. Device class: 2.
Clearance details
- Applicant
- Inverness Medical Professional Diagnostics
- 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
- Special
- Location
- Scarborough, ME, US
Recent devices under product code MJH
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