510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130011Unknown

Illumina Miseqdx Platform

Illumina, Inc., San Diego CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN130011 is the FDA 510(k) clearance record for ILLUMINA MISEQDX PLATFORM, a class II device, cleared for Illumina, Inc. on under FDA product code PFF (High Throughput Dna Sequence Analyzer). FDA's definition for product code PFF reads: "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". FDA records list 6 510(k) clearances for Illumina, Inc., from to . As of , FDA records show no recalls naming DEN130011.

Clearance record

Decision date
Received
(57 days to decision)
Product code
PFF High Throughput Dna Sequence Analyzer
Regulation
21 CFR 862.2265
Device class
Class II
Review panel
Immunology
Applicant
Illumina, Inc. 5200 Illumina Way, San Diego CA
Third party review
No

Clearances, product code PFF

Trailing 12 months

FDA records hold no clearances under product code PFF in the trailing twelve months.

FDA records show no clearances under product code PFF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260