ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY— 510(k) K124006

Name: FDA 510(k) clearance K124006
Creator: U.S. Food and Drug Administration
Published: 2013-11-19

Substantially Equivalent

Illumina, Inc.

FDA 510(k) clearance K124006 for ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY, Substantially Equivalent on 2013-11-19. Applicant: Illumina, Inc.. Device class: 2.

Clearance details

Applicant: Illumina, Inc.
Product code: Code PFR
Device class: Class 2
Regulation: 21 CFR 866.5900
Advisory panel: Immunology
Date received: 2012-12-26
Decision date: 2013-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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