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FDA 510(k)

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY

K-Number: K101911 · 2010-10-18

ApplicantCylex, Inc.
Decision Date2010-10-18
Product CodeNID
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION 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 2010-10-18 under 510(k) number K101911. 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 IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY?

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY is a medical device that received FDA 510(k) clearance on 2010-10-18. The listed applicant is Cylex, Inc.. The 510(k) number is K101911.

When did IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY receive FDA 510(k) clearance?

IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY received FDA 510(k) clearance on 2010-10-18, under 510(k) number K101911.

Who is the listed applicant for IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION 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 IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY?

The FDA product code for IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION 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.

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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.

K013169IMMUNE CELL FUNCTION 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.

K013169IMMUNE CELL FUNCTION 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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