MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST— 510(k) K861835

Name: FDA 510(k) clearance K861835
Creator: U.S. Food and Drug Administration
Published: 1986-05-29

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K861835 for MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST, Substantially Equivalent on 1986-05-29. Applicant: Syva Co.. Device class: 2.

Clearance details

Applicant: Syva Co.
Product code: Code GTH
Device class: Class 2
Regulation: 21 CFR 866.3390
Advisory panel: Microbiology
Date received: 1986-05-13
Decision date: 1986-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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