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FDA Product Code

FDA Product Code PFR — Clearance Directory

Device Class
Class II
Assigned Panel
Immunology
21 CFR Citation
866.5900

510(k) Clearances — 1 record

K-Number Device Name Applicant Decision Date Clearance Type Summary
K124006 ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY Illumina, Inc. 2013-11-19 Traditional PDF ↗

Product code PFR · Class II · Immunology. Data: openFDA.