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FDA 510(k)

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

K-Number: K043378 · 2004-12-29

ApplicantDrew Scientific , Ltd.
Decision Date2004-12-29
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR 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 2004-12-29 under 510(k) number K043378. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT?

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT is a medical device that received FDA 510(k) clearance on 2004-12-29. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K043378.

When did DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT receive FDA 510(k) clearance?

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT received FDA 510(k) clearance on 2004-12-29, under 510(k) number K043378.

Who is the listed applicant for DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR 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 LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT?

The FDA product code for DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT is JIT.

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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.

K060510DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KITK012152DS30 HCY BLOOD COLLECTION TUBESK982003DS30 HCY HOMOCYSTEINE ASSAY KITK933287745 GLYCOMATK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITK920198GLYCOMAT HAEMOGLOBIN ANALYSER

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Related Devices (Code: JIT)

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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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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