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510(k) DEN130011

ILLUMINA MISEQDX PLATFORM by Illumina, Inc. — Product Code PFF

DEN130011 is an FDA 510(k) premarket notification submitted by Illumina, Inc. for the device "ILLUMINA MISEQDX PLATFORM". The FDA issued a decision of De Novo Granted on November 19, 2013. The device falls under product code PFF (High Throughput Dna Sequence Analyzer), a Class II device regulated under 21 CFR 862.2265. Illumina, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 19, 2013
Date Received
September 23, 2013
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Throughput Dna Sequence Analyzer
Device Class
Class II
Regulation Number
862.2265
Review Panel
TX
Submission Type

A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.

Other clearances by Illumina, Inc.

  • DEN130042 — MISEQDX UNIVERSAL KIT 1.0 (November 19, 2013)
  • K132750 — ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY (November 19, 2013)
  • K124006 — ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY (November 19, 2013)
  • K093129 — ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II (April 28, 2010)
  • K093128 — ILLUMINA BEADXPRESS SYSTEM (April 28, 2010)

Other clearances for product code PFF

  • K170299 — Ion PGM Dx System (June 22, 2017)

FDA data resources