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FDA 510(k)

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY

K-Number: K124006 · 2013-11-19

ApplicantIllumina, Inc.
Decision Date2013-11-19
Product CodePFR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Illumina, Inc.. It received FDA 510(k) clearance on 2013-11-19 under 510(k) number K124006. The device is classified under product code PFR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY?

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY is a medical device that received FDA 510(k) clearance on 2013-11-19. The listed applicant is Illumina, Inc.. The 510(k) number is K124006.

When did ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY receive FDA 510(k) clearance?

ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY received FDA 510(k) clearance on 2013-11-19, under 510(k) number K124006.

Who is the listed applicant for ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY?

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 MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY?

The FDA product code for ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY is PFR.

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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.

K132750ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAYK093128ILLUMINA BEADXPRESS SYSTEMK093129ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

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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