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FDA 510(k)

CELLSEARCH CIRCULATING TUMOR CELL KIT

K-Number: K050245 · 2005-03-15

ApplicantVeridex, LLC
Decision Date2005-03-15
Product CodeNQI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CELLSEARCH CIRCULATING TUMOR CELL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Veridex, LLC. It received FDA 510(k) clearance on 2005-03-15 under 510(k) number K050245. The device is classified under product code NQI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLSEARCH CIRCULATING TUMOR CELL KIT?

CELLSEARCH CIRCULATING TUMOR CELL KIT is a medical device that received FDA 510(k) clearance on 2005-03-15. The listed applicant is Veridex, LLC. The 510(k) number is K050245.

When did CELLSEARCH CIRCULATING TUMOR CELL KIT receive FDA 510(k) clearance?

CELLSEARCH CIRCULATING TUMOR CELL KIT received FDA 510(k) clearance on 2005-03-15, under 510(k) number K050245.

Who is the listed applicant for CELLSEARCH CIRCULATING TUMOR CELL KIT?

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 CELLSEARCH CIRCULATING TUMOR CELL KIT?

The FDA product code for CELLSEARCH CIRCULATING TUMOR CELL KIT is NQI.

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 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 7900001K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541

View all 12 devices →

Related Devices (Code: NQI)

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 SYSTEMVeridex, LLCK122821CELLTRACKS AUTOPREP SYSTEMVeridex, LLCK110406CELLTRACKS AUTOPREP SYSTEMVeridex, LLCK113181CELLTRACKS ANALYER IIVeridex, LLCK103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001Veridex, LLCK073338CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLC

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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