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FDA 510(k)

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

K-Number: K093129 · 2010-04-28

ApplicantIllumina, Inc.
Decision Date2010-04-28
Product CodeNPQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II is the device name listed in this FDA 510(k) record. The listed applicant is Illumina, Inc.. It received FDA 510(k) clearance on 2010-04-28 under 510(k) number K093129. The device is classified under product code NPQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II?

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II is a medical device that received FDA 510(k) clearance on 2010-04-28. The listed applicant is Illumina, Inc.. The 510(k) number is K093129.

When did ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II receive FDA 510(k) clearance?

ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II received FDA 510(k) clearance on 2010-04-28, under 510(k) number K093129.

Who is the listed applicant for ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II?

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

What is the FDA product code for ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II?

The FDA product code for ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II is NPQ.

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Other records listing Illumina, 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.

K124006ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAYK132750ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAYK093128ILLUMINA BEADXPRESS SYSTEM

Related Devices (Code: NPQ)

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.

K100980INVADER FACTOR VHologic, Inc.K093974ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPINGOsmetech Molecular DiagnosticsK082118XPERT HEMOSIL FACTOR II & FACTOR V ASSAYCepheidK060564INFINITI SYSTEMAutoGenomics, 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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