THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE— 510(k) K871105

Name: FDA 510(k) clearance K871105
Creator: U.S. Food and Drug Administration
Published: 1987-05-13

Substantially Equivalent

New 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.. Device class: 2.

Clearance details

Applicant: New Horizons Diagnostics Co.
Product code: Code LIC
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1987-03-19
Decision date: 1987-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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