ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER— 510(k) K944192

Name: FDA 510(k) clearance K944192
Creator: U.S. Food and Drug Administration
Published: 1995-03-06

Substantially Equivalent

Light Diagnostics

FDA 510(k) clearance K944192 for ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER, Substantially Equivalent on 1995-03-06. Applicant: Light Diagnostics. Device class: 2.

Clearance details

Applicant: Light Diagnostics
Product code: Code DBL
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1994-08-29
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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