ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)— 510(k) K030528

Name: FDA 510(k) clearance K030528
Creator: U.S. Food and Drug Administration
Published: 2003-06-17

Substantially Equivalent

Clinical Data

FDA 510(k) clearance K030528 for ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL), Substantially Equivalent on 2003-06-17. Applicant: Clinical Data. Device class: 1.

Clearance details

Applicant: Clinical Data
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 2003-02-19
Decision date: 2003-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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