ATAC TOTAL BILIRUBIN REAGENT— 510(k) K030014

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K030014 for ATAC TOTAL BILIRUBIN REAGENT, Substantially Equivalent on 2003-09-26. 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: 2003-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Elan Diagnostics

K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR2003-09-29
K030621 — ATAC CALIBRATOR2003-03-19
K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR2003-03-13
K030010 — ATAC PAK MAGNESIUM REAGENT2003-03-10
K030006 — ATAC PAK ALBUMIN REAGENT2003-03-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.