Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CELLSEARCH EPITHELIAL CELL CONTROL KIT

K-Number: K040898 · 2004-06-28

ApplicantVeridex, LLC
Decision Date2004-06-28
Product CodeNRS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CELLSEARCH EPITHELIAL CELL CONTROL 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 2004-06-28 under 510(k) number K040898. The device is classified under product code NRS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLSEARCH EPITHELIAL CELL CONTROL KIT?

CELLSEARCH EPITHELIAL CELL CONTROL KIT is a medical device that received FDA 510(k) clearance on 2004-06-28. The listed applicant is Veridex, LLC. The 510(k) number is K040898.

When did CELLSEARCH EPITHELIAL CELL CONTROL KIT receive FDA 510(k) clearance?

CELLSEARCH EPITHELIAL CELL CONTROL KIT received FDA 510(k) clearance on 2004-06-28, under 510(k) number K040898.

Who is the listed applicant for CELLSEARCH EPITHELIAL CELL CONTROL 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 EPITHELIAL CELL CONTROL KIT?

The FDA product code for CELLSEARCH EPITHELIAL CELL CONTROL KIT is NRS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 →

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.

↑