LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B— 510(k) K974302

Name: FDA 510(k) clearance K974302
Creator: U.S. Food and Drug Administration
Published: 1998-04-08

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K974302 for LIGHT DIAGNOSTICS SIMULFLUOR FLU A/FLU B, Substantially Equivalent on 1998-04-08. Applicant: Light Diagnostics. Device class: 1.

Clearance details

Applicant: Light Diagnostics
Product code: Code GNW
Device class: Class 1
Regulation: 21 CFR 866.3330
Advisory panel: Microbiology
Date received: 1997-11-17
Decision date: 1998-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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