NEISSERIA GONORRHOEAE TEST— 510(k) K820007

Name: FDA 510(k) clearance K820007
Creator: U.S. Food and Drug Administration
Published: 1982-01-29

Substantially Equivalent

New Horizons Diagnostics Co.

FDA 510(k) clearance K820007 for NEISSERIA GONORRHOEAE TEST, Substantially Equivalent on 1982-01-29. 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: 1982-01-04
Decision date: 1982-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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