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FDA 510(k)

VACUETTE TRACE ELEMENTS TUBES

K-Number: K023971 · 2003-01-27

ApplicantGreiner Bio-One Vacuette North America
Decision Date2003-01-27
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUETTE TRACE ELEMENTS TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Vacuette North America. It received FDA 510(k) clearance on 2003-01-27 under 510(k) number K023971. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUETTE TRACE ELEMENTS TUBES?

VACUETTE TRACE ELEMENTS TUBES is a medical device that received FDA 510(k) clearance on 2003-01-27. The listed applicant is Greiner Bio-One Vacuette North America. The 510(k) number is K023971.

When did VACUETTE TRACE ELEMENTS TUBES receive FDA 510(k) clearance?

VACUETTE TRACE ELEMENTS TUBES received FDA 510(k) clearance on 2003-01-27, under 510(k) number K023971.

Who is the listed applicant for VACUETTE TRACE ELEMENTS TUBES?

The FDA 510(k) record lists Greiner Bio-One Vacuette North America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUETTE TRACE ELEMENTS TUBES?

The FDA product code for VACUETTE TRACE ELEMENTS TUBES is JKA.

Related Clinical Trials

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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Other records listing Greiner Bio-One Vacuette North America 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.

K080235SAFETY INFUSION SETK042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESK033478VACUETTE QUICKSHIELD SAFETY TUBE HOLDERK011699VACUETTE EVACUATED BLOOD COLLECTION TUBES

Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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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