LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295— 510(k) K990141

Name: FDA 510(k) clearance K990141
Creator: U.S. Food and Drug Administration
Published: 1999-10-19

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K990141 for LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295, Substantially Equivalent on 1999-10-19. Applicant: Light Diagnostics. Device class: 2.

Clearance details

Applicant: Light Diagnostics
Product code: Code GQW
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1999-01-19
Decision date: 1999-10-19
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.