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FDA 510(k)

VACUETTE EVACUATED BLOOD COLLECTION TUBES

K-Number: K011699 · 2001-06-28

ApplicantGreiner Bio-One Vacuette North America
Decision Date2001-06-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUETTE EVACUATED BLOOD COLLECTION 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 2001-06-28 under 510(k) number K011699. 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 EVACUATED BLOOD COLLECTION TUBES?

VACUETTE EVACUATED BLOOD COLLECTION TUBES is a medical device that received FDA 510(k) clearance on 2001-06-28. The listed applicant is Greiner Bio-One Vacuette North America. The 510(k) number is K011699.

When did VACUETTE EVACUATED BLOOD COLLECTION TUBES receive FDA 510(k) clearance?

VACUETTE EVACUATED BLOOD COLLECTION TUBES received FDA 510(k) clearance on 2001-06-28, under 510(k) number K011699.

Who is the listed applicant for VACUETTE EVACUATED BLOOD COLLECTION 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 EVACUATED BLOOD COLLECTION TUBES?

The FDA product code for VACUETTE EVACUATED BLOOD COLLECTION TUBES is JKA.

Related Clinical Trials

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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 HOLDERK023971VACUETTE TRACE ELEMENTS 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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