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FDA Product Code

FDA Product Code PFS — 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
K132750 ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY Illumina, Inc. 2013-11-19 Traditional PDF ↗

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