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FDA 510(k)

Kurin Blood Culture Collection Set

K-Number: K162233 · 2016-12-23

ApplicantPathway, LLC
Decision Date2016-12-23
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kurin Blood Culture Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is Pathway, LLC. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K162233. 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 Kurin Blood Culture Collection Set?

Kurin Blood Culture Collection Set is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Pathway, LLC. The 510(k) number is K162233.

When did Kurin Blood Culture Collection Set receive FDA 510(k) clearance?

Kurin Blood Culture Collection Set received FDA 510(k) clearance on 2016-12-23, under 510(k) number K162233.

Who is the listed applicant for Kurin Blood Culture Collection Set?

The FDA 510(k) record lists Pathway, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kurin Blood Culture Collection Set?

The FDA product code for Kurin Blood Culture Collection Set is JKA.

Other records listing Pathway, LLC 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.

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 CompanyK251812Steripath® Flow™ Blood Collection SystemMagnolia Medical Technologies

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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