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FDA 510(k)

EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS

K-Number: K071648 · 2007-08-22

ApplicantCanterbury Scientific , Ltd.
Decision Date2007-08-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS 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 2007-08-22 under 510(k) number K071648. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS?

EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS is a medical device that received FDA 510(k) clearance on 2007-08-22. The listed applicant is Canterbury Scientific , Ltd.. The 510(k) number is K071648.

When did EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS receive FDA 510(k) clearance?

EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS received FDA 510(k) clearance on 2007-08-22, under 510(k) number K071648.

Who is the listed applicant for EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS?

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 EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS?

The FDA product code for EXTENDSURE LYOPHILIZED HBA1C LINEARITY CONTROLS is JJX.

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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.

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Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.

Official Source

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

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