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FDA 510(k)

CELLTRACKA ANALYZER II

K-Number: K050145 · 2005-03-15

ApplicantImmunicon Corp.
Decision Date2005-03-15
Product CodeNQI
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CELLTRACKA ANALYZER II is the device name listed in this FDA 510(k) record. The listed applicant is Immunicon Corp.. It received FDA 510(k) clearance on 2005-03-15 under 510(k) number K050145. 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 CELLTRACKA ANALYZER II?

CELLTRACKA ANALYZER II is a medical device that received FDA 510(k) clearance on 2005-03-15. The listed applicant is Immunicon Corp.. The 510(k) number is K050145.

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

CELLTRACKA ANALYZER II received FDA 510(k) clearance on 2005-03-15, under 510(k) number K050145.

Who is the listed applicant for CELLTRACKA ANALYZER II?

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 CELLTRACKA ANALYZER II?

The FDA product code for CELLTRACKA ANALYZER II 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.

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 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 IIK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMK030263IMMUNICON CELLTRACKS ANALYZERK030596IMMUNICON CELLSAVE PRESERVATIVE TUBEK022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518

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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