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FDA 510(k)

VACUPLUS(R) STAR-SEP(TM)

K-Number: K924363 · 1993-02-08

ApplicantStarplex Scientific, Inc.
Decision Date1993-02-08
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUPLUS(R) STAR-SEP(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Starplex Scientific, Inc.. It received FDA 510(k) clearance on 1993-02-08 under 510(k) number K924363. 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 VACUPLUS(R) STAR-SEP(TM)?

VACUPLUS(R) STAR-SEP(TM) is a medical device that received FDA 510(k) clearance on 1993-02-08. The listed applicant is Starplex Scientific, Inc.. The 510(k) number is K924363.

When did VACUPLUS(R) STAR-SEP(TM) receive FDA 510(k) clearance?

VACUPLUS(R) STAR-SEP(TM) received FDA 510(k) clearance on 1993-02-08, under 510(k) number K924363.

Who is the listed applicant for VACUPLUS(R) STAR-SEP(TM)?

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

What is the FDA product code for VACUPLUS(R) STAR-SEP(TM)?

The FDA product code for VACUPLUS(R) STAR-SEP(TM) is JKA.

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Other records listing Starplex Scientific, 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 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 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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