FDA 510(k)

VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE

K-Number: K981013 · 1998-06-17

ApplicantBecton Dickinson Vacutainer Systems

Decision Date1998-06-17

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent for Some Indications

Device Summary

VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Vacutainer Systems. It received FDA 510(k) clearance on 1998-06-17 under 510(k) number K981013. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE?

VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE is a medical device that received FDA 510(k) clearance on 1998-06-17. The listed applicant is Becton Dickinson Vacutainer Systems. The 510(k) number is K981013.

When did VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE receive FDA 510(k) clearance?

VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE received FDA 510(k) clearance on 1998-06-17, under 510(k) number K981013.

Who is the listed applicant for VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE?

The FDA 510(k) record lists Becton Dickinson Vacutainer Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE?

The FDA product code for VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE is JKA.

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Other records listing Becton Dickinson Vacutainer Systems as applicant

K002456MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 K991088VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE K991120VACUTAINER BRAND CTAD TUBE (MULTIPLE)K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 K982922VACUTAINER BRAND BLOOD COLLECTION SYRINGE

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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.