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FDA 510(k)

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

K-Number: K132750 · 2013-11-19

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

Device Summary

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING 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 K132750. The device is classified under product code PFS. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY?

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING 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 K132750.

When did ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY receive FDA 510(k) clearance?

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY received FDA 510(k) clearance on 2013-11-19, under 510(k) number K132750.

Who is the listed applicant for ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING 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 CLINICAL SEQUENCING ASSAY?

The FDA product code for ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY is PFS.

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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 ASSAYK093128ILLUMINA BEADXPRESS SYSTEMK093129ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II

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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