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FDA 510(k)

INFINITI CYP2C19 ASSAY

K-Number: K101683 · 2010-10-25

ApplicantAutogenomics, Incorporated
Decision Date2010-10-25
Product CodeNTI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

INFINITI CYP2C19 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Autogenomics, Incorporated. It received FDA 510(k) clearance on 2010-10-25 under 510(k) number K101683. 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 INFINITI CYP2C19 ASSAY?

INFINITI CYP2C19 ASSAY is a medical device that received FDA 510(k) clearance on 2010-10-25. The listed applicant is Autogenomics, Incorporated. The 510(k) number is K101683.

When did INFINITI CYP2C19 ASSAY receive FDA 510(k) clearance?

INFINITI CYP2C19 ASSAY received FDA 510(k) clearance on 2010-10-25, under 510(k) number K101683.

Who is the listed applicant for INFINITI CYP2C19 ASSAY?

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

What is the FDA product code for INFINITI CYP2C19 ASSAY?

The FDA product code for INFINITI CYP2C19 ASSAY is NTI.

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 Autogenomics, Incorporated 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.

K073014INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN

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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