LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY— 510(k) K991880

Name: FDA 510(k) clearance K991880
Creator: U.S. Food and Drug Administration
Published: 1999-11-09

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K991880 for LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY, Substantially Equivalent on 1999-11-09. Applicant: Light Diagnostics. Device class: 2.

Clearance details

Applicant: Light Diagnostics
Product code: Code GQN
Device class: Class 2
Regulation: 21 CFR 866.3305
Advisory panel: Microbiology
Date received: 1999-06-02
Decision date: 1999-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.