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FDA 510(k)

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

K-Number: K022512 · 2002-09-30

ApplicantImmunicon Corp.
Decision Date2002-09-30
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 is the device name listed in this FDA 510(k) record. The listed applicant is Immunicon Corp.. It received FDA 510(k) clearance on 2002-09-30 under 510(k) number K022512. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518?

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 is a medical device that received FDA 510(k) clearance on 2002-09-30. The listed applicant is Immunicon Corp.. The 510(k) number is K022512.

When did CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 receive FDA 510(k) clearance?

CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 received FDA 510(k) clearance on 2002-09-30, under 510(k) number K022512.

Who is the listed applicant for CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518?

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 CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518?

The FDA product code for CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 is GKH.

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 ANALYZERK030596IMMUNICON CELLSAVE PRESERVATIVE TUBE

Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K923530COULTER MULTI-Q-PREPCoulter Electronics, Inc.K904795FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEMBd Becton Dickinson Vacutainer Systems Preanalytic

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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