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FDA 510(k)

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT

K-Number: K060510 · 2006-06-19

ApplicantDrew Scientific , Ltd.
Decision Date2006-06-19
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Drew Scientific , Ltd.. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K060510. 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 DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT?

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K060510.

When did DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT receive FDA 510(k) clearance?

DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT received FDA 510(k) clearance on 2006-06-19, under 510(k) number K060510.

Who is the listed applicant for DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT?

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

What is the FDA product code for DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT?

The FDA product code for DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT is JJX.

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Other records listing Drew 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.

K043378DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITK012152DS30 HCY BLOOD COLLECTION TUBESK982003DS30 HCY HOMOCYSTEINE ASSAY KITK933287745 GLYCOMATK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITK920198GLYCOMAT HAEMOGLOBIN ANALYSER

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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

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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