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FDA 510(k)

Monarch Blood Collection Set

K-Number: K232308 · 2023-12-04

ApplicantThe Monarch Company
Decision Date2023-12-04
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Monarch Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is The Monarch Company. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K232308. 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 Monarch Blood Collection Set?

Monarch Blood Collection Set is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is The Monarch Company. The 510(k) number is K232308.

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

Monarch Blood Collection Set received FDA 510(k) clearance on 2023-12-04, under 510(k) number K232308.

Who is the listed applicant for Monarch Blood Collection Set?

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

What is the FDA product code for Monarch Blood Collection Set?

The FDA product code for Monarch Blood Collection Set is JKA.

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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