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FDA 510(k)

HEMOGLOBIN A1C CONTROL

K-Number: K021484 · 2002-06-14

ApplicantCanterbury Scientific , Ltd.
Decision Date2002-06-14
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOGLOBIN A1C CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Canterbury Scientific , Ltd.. It received FDA 510(k) clearance on 2002-06-14 under 510(k) number K021484. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOGLOBIN A1C CONTROL?

HEMOGLOBIN A1C CONTROL is a medical device that received FDA 510(k) clearance on 2002-06-14. The listed applicant is Canterbury Scientific , Ltd.. The 510(k) number is K021484.

When did HEMOGLOBIN A1C CONTROL receive FDA 510(k) clearance?

HEMOGLOBIN A1C CONTROL received FDA 510(k) clearance on 2002-06-14, under 510(k) number K021484.

Who is the listed applicant for HEMOGLOBIN A1C CONTROL?

The FDA 510(k) record lists Canterbury Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOGLOBIN A1C CONTROL?

The FDA product code for HEMOGLOBIN A1C CONTROL is LCP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Canterbury Scientific , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071648EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLSK043070LIQUID STABLE HBA1C CONTROL

Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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