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FDA 510(k)

HBA1C LINEARITY SET

K-Number: K052010 · 2005-10-04

ApplicantCone Bioproducts
Decision Date2005-10-04
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HBA1C LINEARITY SET is the device name listed in this FDA 510(k) record. The listed applicant is Cone Bioproducts. It received FDA 510(k) clearance on 2005-10-04 under 510(k) number K052010. 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 HBA1C LINEARITY SET?

HBA1C LINEARITY SET is a medical device that received FDA 510(k) clearance on 2005-10-04. The listed applicant is Cone Bioproducts. The 510(k) number is K052010.

When did HBA1C LINEARITY SET receive FDA 510(k) clearance?

HBA1C LINEARITY SET received FDA 510(k) clearance on 2005-10-04, under 510(k) number K052010.

Who is the listed applicant for HBA1C LINEARITY SET?

The FDA 510(k) record lists Cone Bioproducts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HBA1C LINEARITY SET?

The FDA product code for HBA1C LINEARITY SET is JJX.

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Other records listing Cone Bioproducts 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.

K121759CONE-TROL LIQUID CHEMISTRY CONTROLSK121534CONE-TROL HEMOGLOBIN A1C CONTROL SET

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

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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