FDA 510(k)

VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR

K-Number: K103041 · 2010-11-09

ApplicantGreiner Bio-One North America, Inc.

Decision Date2010-11-09

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One North America, Inc.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K103041. 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 BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR?

VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Greiner Bio-One North America, Inc.. The 510(k) number is K103041.

When did VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR receive FDA 510(k) clearance?

VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR received FDA 510(k) clearance on 2010-11-09, under 510(k) number K103041.

Who is the listed applicant for VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR?

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

What is the FDA product code for VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR?

The FDA product code for VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR is JKA.

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Other records listing Greiner Bio-One North America, Inc. as applicant

K233979VACUETTE® QUICKSHIELD Complete (Plus)K122687BLOOD CULTURE HOLDER K121908SAFETY INFUSION SET K113505VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER K102774VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER K081929VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR

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Related Devices (Code: JKA)

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 Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252040BD 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.