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.
Clearance details
- Applicant
- Inverness Medical Professional Diagnostics
- Product code
- Code MJH
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Scarborough, ME, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.