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FDA 510(k)

IMMUNICON CELLTRACKS ANALYZER

K-Number: K030263 · 2003-11-24

ApplicantImmunicon Corp.
Decision Date2003-11-24
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNICON CELLTRACKS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Immunicon Corp.. It received FDA 510(k) clearance on 2003-11-24 under 510(k) number K030263. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNICON CELLTRACKS ANALYZER?

IMMUNICON CELLTRACKS ANALYZER is a medical device that received FDA 510(k) clearance on 2003-11-24. The listed applicant is Immunicon Corp.. The 510(k) number is K030263.

When did IMMUNICON CELLTRACKS ANALYZER receive FDA 510(k) clearance?

IMMUNICON CELLTRACKS ANALYZER received FDA 510(k) clearance on 2003-11-24, under 510(k) number K030263.

Who is the listed applicant for IMMUNICON CELLTRACKS ANALYZER?

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 CELLTRACKS ANALYZER?

The FDA product code for IMMUNICON CELLTRACKS ANALYZER is GKZ.

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 SYSTEMK030596IMMUNICON CELLSAVE PRESERVATIVE TUBEK022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

Related Devices (Code: GKZ)

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.

K260781Yumizen H550HORIBA ABX SASK253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc.K243348Athelas HomeAthelas, Inc.K251249Tru Hematology TestTruvian Sciences, Inc.K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc.K251371Sysmex XR-Series (XR-20) Automated Hematology AnalyzerSysmex America, Inc.

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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