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FDA 510(k)

CELLTRACKS ANALYZER II SYSTEM

K-Number: K130794 · 2013-06-20

ApplicantVeridex, LLC
Decision Date2013-06-20
Product CodeNQI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CELLTRACKS ANALYZER II SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Veridex, LLC. It received FDA 510(k) clearance on 2013-06-20 under 510(k) number K130794. 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 CELLTRACKS ANALYZER II SYSTEM?

CELLTRACKS ANALYZER II SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-20. The listed applicant is Veridex, LLC. The 510(k) number is K130794.

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

CELLTRACKS ANALYZER II SYSTEM received FDA 510(k) clearance on 2013-06-20, under 510(k) number K130794.

Who is the listed applicant for CELLTRACKS ANALYZER II SYSTEM?

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 ANALYZER II SYSTEM?

The FDA product code for CELLTRACKS ANALYZER II SYSTEM is NQI.

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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.

K122821CELLTRACKS AUTOPREP SYSTEMK110406CELLTRACKS AUTOPREP SYSTEMK113181CELLTRACKS ANALYER IIK103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541K073338CELLSEARCH CIRCULATING TUMOR CELL KIT

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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.

K122821CELLTRACKS AUTOPREP SYSTEMVeridex, LLCK110406CELLTRACKS AUTOPREP SYSTEMVeridex, LLCK113181CELLTRACKS ANALYER IIVeridex, LLCK103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001Veridex, LLCK073338CELLSEARCH CIRCULATING TUMOR CELL KITVeridex, LLCK071729CELLSEARCH 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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