Cleared Traditional

Ion PGM Dx System

K170299 · Life Technologies Corporation · Chemistry
Jun 2017
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K170299 is an FDA 510(k) clearance for the Ion PGM Dx System, a High Throughput Dna Sequence Analyzer (Class II — Special Controls, product code PFF), submitted by Life Technologies Corporation (Carlbad, US). The FDA issued a Cleared decision on June 22, 2017, 142 days after receiving the submission on January 31, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2265.

Submission Details

510(k) Number K170299 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2017
Decision Date June 22, 2017
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code PFF — High Throughput Dna Sequence Analyzer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.2265
Definition 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.