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FDA 510(k)

DS30 HCY BLOOD COLLECTION TUBES

K-Number: K012152 · 2001-09-18

ApplicantDrew Scientific , Ltd.
Decision Date2001-09-18
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DS30 HCY BLOOD COLLECTION TUBES 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 2001-09-18 under 510(k) number K012152. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DS30 HCY BLOOD COLLECTION TUBES?

DS30 HCY BLOOD COLLECTION TUBES is a medical device that received FDA 510(k) clearance on 2001-09-18. The listed applicant is Drew Scientific , Ltd.. The 510(k) number is K012152.

When did DS30 HCY BLOOD COLLECTION TUBES receive FDA 510(k) clearance?

DS30 HCY BLOOD COLLECTION TUBES received FDA 510(k) clearance on 2001-09-18, under 510(k) number K012152.

Who is the listed applicant for DS30 HCY BLOOD COLLECTION TUBES?

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 DS30 HCY BLOOD COLLECTION TUBES?

The FDA product code for DS30 HCY BLOOD COLLECTION TUBES is GIM.

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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 KITK043378DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KITK982003DS30 HCY HOMOCYSTEINE ASSAY KITK933287745 GLYCOMATK924496GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KITK920198GLYCOMAT HAEMOGLOBIN ANALYSER

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Related Devices (Code: GIM)

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.

K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and CompanyK230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and CompanyK213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson and CompanyK162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd.K080552CYTO-CHEX BCTStreckK971449VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)Becton Dickinson Vacutainer Systems

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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