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FDA 510(k)

XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)

K-Number: K093420 · 2010-08-26

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2010-08-26
Product CodeNTI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2010-08-26 under 510(k) number K093420. The device is classified under product code NTI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)?

XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) is a medical device that received FDA 510(k) clearance on 2010-08-26. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K093420.

When did XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) receive FDA 510(k) clearance?

XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) received FDA 510(k) clearance on 2010-08-26, under 510(k) number K093420.

Who is the listed applicant for XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)?

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

What is the FDA product code for XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)?

The FDA product code for XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) is NTI.

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Other records listing Luminex Molecular Diagnostics, Inc. as applicant

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K242613NxTAG® Respiratory Pathogen PanelK231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareK191161xTAG Gastrointestinal Pathogen Panel (GPP)K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

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Related Devices (Code: NTI)

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.

K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc.K170492xTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc.K131565XTAG CYP2C19 KIT V3Luminex Molecular Diagnostics, Inc.K123891SPARTAN RX CYP2C19 TEST SYSTEMSpartan Bioscience, Inc.K130189XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)Luminex Molecular Diagnostics, Inc.K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)Nanosphere, Inc.

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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