HEMOGLOBIN A1C CONTROL— 510(k) K021484

Name: FDA 510(k) clearance K021484
Creator: U.S. Food and Drug Administration
Published: 2002-06-14

Substantially Equivalent

Canterbury Scientific , Ltd.

FDA 510(k) clearance K021484 for HEMOGLOBIN A1C CONTROL, Substantially Equivalent on 2002-06-14. Applicant: Canterbury Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Canterbury Scientific , Ltd.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2002-05-08
Decision date: 2002-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Christchurch, NZ

Download summary PDF View on FDA.gov ↗

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Recalls naming K021484

K-number listed on FDA's recall record

Z-0601-2019 — Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.Class III·Terminated·Tosoh Bioscience Inc·20181005

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021484.

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