DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR— 510(k) K050266

Name: FDA 510(k) clearance K050266
Creator: U.S. Food and Drug Administration
Published: 2005-06-30

Substantially Equivalent

Stanbio Laboratory

FDA 510(k) clearance K050266 for DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR, Substantially Equivalent on 2005-06-30. Applicant: Stanbio Laboratory. Device class: 2.

Clearance details

Applicant: Stanbio Laboratory
Product code: Code JFM
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2005-02-04
Decision date: 2005-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boerne, TX, US

Download summary PDF View on FDA.gov ↗

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