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FDA 510(k)

IMMUNICON CELLSAVE PRESERVATIVE TUBE

K-Number: K030596 · 2003-08-08

ApplicantImmunicon Corp.
Decision Date2003-08-08
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNICON CELLSAVE PRESERVATIVE TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Immunicon Corp.. It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K030596. 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 IMMUNICON CELLSAVE PRESERVATIVE TUBE?

IMMUNICON CELLSAVE PRESERVATIVE TUBE is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Immunicon Corp.. The 510(k) number is K030596.

When did IMMUNICON CELLSAVE PRESERVATIVE TUBE receive FDA 510(k) clearance?

IMMUNICON CELLSAVE PRESERVATIVE TUBE received FDA 510(k) clearance on 2003-08-08, under 510(k) number K030596.

Who is the listed applicant for IMMUNICON CELLSAVE PRESERVATIVE TUBE?

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

What is the FDA product code for IMMUNICON CELLSAVE PRESERVATIVE TUBE?

The FDA product code for IMMUNICON CELLSAVE PRESERVATIVE TUBE is JKA.

Related Clinical Trials

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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Other records listing Immunicon Corp. 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.

K060110CELLTRACKS ANALYZER IIK050145CELLTRACKA ANALYZER IIK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMK030263IMMUNICON CELLTRACKS ANALYZERK022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

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

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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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