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FDA 510(k)

IMMUNE CELL FUNCTION ASSAY

K-Number: K013169 · 2002-04-02

ApplicantCylex, Inc.
Decision Date2002-04-02
Product CodeNID
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUNE CELL FUNCTION ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cylex, Inc.. It received FDA 510(k) clearance on 2002-04-02 under 510(k) number K013169. The device is classified under product code NID. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNE CELL FUNCTION ASSAY?

IMMUNE CELL FUNCTION ASSAY is a medical device that received FDA 510(k) clearance on 2002-04-02. The listed applicant is Cylex, Inc.. The 510(k) number is K013169.

When did IMMUNE CELL FUNCTION ASSAY receive FDA 510(k) clearance?

IMMUNE CELL FUNCTION ASSAY received FDA 510(k) clearance on 2002-04-02, under 510(k) number K013169.

Who is the listed applicant for IMMUNE CELL FUNCTION ASSAY?

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

What is the FDA product code for IMMUNE CELL FUNCTION ASSAY?

The FDA product code for IMMUNE CELL FUNCTION ASSAY is NID.

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 Cylex, Inc. 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.

K101911IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

Related Devices (Code: NID)

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.

K101911IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAYCylex, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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