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FDA 510(k)

VACUETTE WITH PPACK

K-Number: K002777 · 2000-10-05

ApplicantGreiner Vacuette North America, Inc.
Decision Date2000-10-05
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUETTE WITH PPACK is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Vacuette North America, Inc.. It received FDA 510(k) clearance on 2000-10-05 under 510(k) number K002777. 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 WITH PPACK?

VACUETTE WITH PPACK is a medical device that received FDA 510(k) clearance on 2000-10-05. The listed applicant is Greiner Vacuette North America, Inc.. The 510(k) number is K002777.

When did VACUETTE WITH PPACK receive FDA 510(k) clearance?

VACUETTE WITH PPACK received FDA 510(k) clearance on 2000-10-05, under 510(k) number K002777.

Who is the listed applicant for VACUETTE WITH PPACK?

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

What is the FDA product code for VACUETTE WITH PPACK?

The FDA product code for VACUETTE WITH PPACK 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 Vacuette North America, Inc. 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.

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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 CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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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