ATAC PAK MAGNESIUM REAGENT— 510(k) K030010

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K030010 for ATAC PAK MAGNESIUM REAGENT, Substantially Equivalent on 2003-03-10. Applicant: Elan Diagnostics. Device class: 1.

Clearance details

Applicant: Elan Diagnostics
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 2003-01-02
Decision date: 2003-03-10
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
K030014 — ATAC TOTAL BILIRUBIN REAGENT2003-09-26
K030621 — ATAC CALIBRATOR2003-03-19
K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR2003-03-13
K030006 — ATAC PAK ALBUMIN REAGENT2003-03-07

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