THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE— 510(k) K871105
Substantially EquivalentNew Horizons Diagnostics Co.
FDA 510(k) clearance K871105 for THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE, Substantially Equivalent on 1987-05-13. Applicant: New Horizons Diagnostics Co..
Clearance details
- Applicant
- New Horizons Diagnostics Co.
- Product code
- Code LIC
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Columbia, MD, US
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