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FDA 510(k)

CELLTRACKS AUTOPREP SYSTEM MODEL:9541

K-Number: K100684 · 2010-08-26

ApplicantVeridex, LLC
Decision Date2010-08-26
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLTRACKS AUTOPREP SYSTEM MODEL:9541 is the device name listed in this FDA 510(k) record. The listed applicant is Veridex, LLC. It received FDA 510(k) clearance on 2010-08-26 under 510(k) number K100684. 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 CELLTRACKS AUTOPREP SYSTEM MODEL:9541?

CELLTRACKS AUTOPREP SYSTEM MODEL:9541 is a medical device that received FDA 510(k) clearance on 2010-08-26. The listed applicant is Veridex, LLC. The 510(k) number is K100684.

When did CELLTRACKS AUTOPREP SYSTEM MODEL:9541 receive FDA 510(k) clearance?

CELLTRACKS AUTOPREP SYSTEM MODEL:9541 received FDA 510(k) clearance on 2010-08-26, under 510(k) number K100684.

Who is the listed applicant for CELLTRACKS AUTOPREP SYSTEM MODEL:9541?

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

What is the FDA product code for CELLTRACKS AUTOPREP SYSTEM MODEL:9541?

The FDA product code for CELLTRACKS AUTOPREP SYSTEM MODEL:9541 is GKH.

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Other records listing Veridex, LLC 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.

K130794CELLTRACKS ANALYZER II SYSTEMK122821CELLTRACKS AUTOPREP SYSTEMK110406CELLTRACKS AUTOPREP SYSTEMK113181CELLTRACKS ANALYER IIK103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001K073338CELLSEARCH CIRCULATING TUMOR CELL KIT

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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.

K040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon 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

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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