ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR— 510(k) K030003

Name: FDA 510(k) clearance K030003
Creator: U.S. Food and Drug Administration
Published: 2003-09-29

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K030003 for ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR, Substantially Equivalent on 2003-09-29. Applicant: Elan Diagnostics. Device class: 2.

Clearance details

Applicant: Elan Diagnostics
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2003-01-02
Decision date: 2003-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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